Rochester, NY, United States
Ortho-Clinical Diagnostics, Inc. recalls
70 recalls recorded since 2018, most recently on 29 July 2025. 41 are listed as ongoing. Status and classification are as published by the FDA.
Recalls70
Ongoing (FDA)41
Terminated or completed29
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 July 2025
- Reason
- VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2560-2025, Z-2559-2025
- VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
- Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
Ongoing Class II Medical devices
- Recall started
- 9 July 2025
- Reason
- Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2335-2025
- VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ongoing Class II Medical devices
- Recall started
- 12 June 2025
- Reason
- Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2073-2025
- VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit cont
Ongoing Class II Medical devices
- Recall started
- 10 June 2025
- Reason
- Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapor
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2120-2025, Z-2121-2025, Z-2122-2025, Z-2123-2025
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Perf
- Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Ver
- VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
- VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Ongoing Class II Medical devices
- Recall started
- 9 May 2025
- Reason
- a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2039-2025, Z-2040-2025, Z-2038-2025
- Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Descriptio
- Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vi
- Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Ongoing Class II Medical devices
- Recall started
- 14 April 2025
- Reason
- Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CO, FL, GA, ID, IL, IN, KS, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI, WV & WY and the countries of Canada, Chile, Colombia, France, India, Italy, Mexico & Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1876-2025
- VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Ongoing Class II Medical devices
- Recall started
- 24 March 2025
- Reason
- It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
- Distribution
- Please see the attached list "Consignee List_CL2025-120." Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary. One (1) Distributor was affected. The other four(4) Distributors were sent the notification for information only. Quide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1948-2025
- Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests.
Ongoing Class II Medical devices
- Recall started
- 19 December 2024
- Reason
- The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1006-2025, Z-1005-2025, Z-1007-2025
- Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diag
- Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In v
- Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description
Ongoing Class II Medical devices
- Recall started
- 11 October 2024
- Reason
- May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0535-2025
- VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Ongoing Class II Medical devices
- Recall started
- 10 July 2024
- Reason
- The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.
- Distribution
- Nationwide. Foreign: Australia Belgium Bermuda Brazil Canada L3R 0B8 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2684-2024
- The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format
Ongoing Class II Medical devices
- Recall started
- 3 July 2024
- Reason
- It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2580-2024
- VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Ongoing Class II Medical devices
- Recall started
- 21 May 2024
- Reason
- VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, NY, PA and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Spain, Singapore, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2266-2024
- VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
Ongoing Class III Medical devices
- Recall started
- 14 May 2024
- Reason
- Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2245-2024
- VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capac
Ongoing Class III Medical devices
- Recall started
- 8 May 2024
- Reason
- The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.
- Distribution
- Worldwide - US Nationwide and the country of Columbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2019-2024
- VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integr
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- Reason
- Potential for positively biased results due to signal reduction over shelf life.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2142-2024
- VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Ongoing Class II Medical devices
- Recall started
- 27 February 2024
- Reason
- The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1372-2024, Z-1373-2024
- VITROS Performance Verifier I
- VITROS Performance Verifier II
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1226-2024, Z-1228-2024, Z-1227-2024, Z-1224-2024, Z-1225-2024
- VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- VITROS XT 7600 Integrated System, Catalog No. 6844461
- VITROS XT 3400 Chemistry System, Catalog No. 6844458
- VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1233-2024, Z-1230-2024, Z-1231-2024, Z-1229-2024, Z-1232-2024
- VITROS XT 7600 Integrated System, Catalog No. 6844461
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- VITROS XT 3400 Chemistry System, Catalog No. 6844458
Ongoing Class II Medical devices
- Recall started
- 22 January 2024
- Reason
- Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1221-2024, Z-1222-2024, Z-1220-2024
- VITROS 5600 Integrated System (New and Refurbished)
- VITROS XT7600 Integrated System
- VITROS 3600 Immunodiagnostic System (New and Refurbished)
Ongoing Class II Medical devices
- Recall started
- 27 November 2023
- Reason
- Affected lots may experience increased calibration failures or an increase in falsely elevated results.
- Distribution
- Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2024
- VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Ongoing Class II Medical devices
- Recall started
- 21 November 2023
- Reason
- Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.
- Distribution
- Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0712-2024
- QMS Tacrolimus Calibrators, Product code 10015573
Ongoing Class II Medical devices
- Recall started
- 25 October 2023
- Reason
- Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.
- Distribution
- Nationwide Foreign: Bermuda Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0510-2024
- VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1
Ongoing Class II Medical devices
- Recall started
- 10 October 2023
- Reason
- During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0546-2024, Z-0544-2024, Z-0547-2024, Z-0545-2024, Z-0543-2024
- VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
- VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
- VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
- VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
- VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Ongoing Class II Medical devices
- Recall started
- 12 September 2023
- Reason
- Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.
- Distribution
- US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0236-2024
- VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Ongoing Class II Medical devices
- Recall started
- 9 August 2023
- Reason
- Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0008-2024
- Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Cod
Ongoing Class II Medical devices
- Recall started
- 5 August 2023
- Reason
- Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2624-2023, Z-2623-2023
- VITROS XT Chemistry Products ALKP Slides
- VITROS XT Chemistry Products TBIL-ALKP Slides
Ongoing Class II Medical devices
- Recall started
- 5 June 2023
- Reason
- Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2357-2023, Z-2358-2023
- VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- VITROS Immunodiagnostic Products Troponin I ES Calibrators
Ongoing Class III Medical devices
- Recall started
- 18 May 2023
- Reason
- May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2225-2023
- VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600
Ongoing Class II Medical devices
- Recall started
- 8 May 2023
- Reason
- Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden , The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2129-2023
- VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Sy
Ongoing Class II Medical devices
- Recall started
- 17 April 2023
- Reason
- Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
- Distribution
- US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1628-2023
- VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Ongoing Class II Medical devices
- Recall started
- 14 April 2023
- Reason
- Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
- Distribution
- Nationwide Foreign: Brazil, Chile, Colombia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1664-2023
- VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calib
Ongoing Class II Medical devices
- Recall started
- 10 March 2023
- Reason
- MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
- Distribution
- Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1556-2023, Z-1555-2023, Z-1557-2023
- VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Che
- VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS
- VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSl
Ongoing Class II Medical devices
- Recall started
- 9 March 2023
- Reason
- Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1396-2023
- VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code:
Ongoing Class II Medical devices
- Recall started
- 17 November 2022
- Reason
- Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0878-2023
- VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
Ongoing Class II Medical devices
- Recall started
- 13 October 2022
- Reason
- Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
- Distribution
- Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0220-2023
- VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,
Ongoing Class II Medical devices
- Recall started
- 19 July 2022
- Reason
- Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1676-2022, Z-1675-2022
- VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
- VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Ongoing Class II Medical devices
- Recall started
- 26 May 2022
- Reason
- On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
- Distribution
- Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1367-2022
- Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Ongoing Class II Medical devices
- Recall started
- 25 March 2022
- Reason
- Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
- Distribution
- Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1113-2022, Z-1112-2022, Z-1114-2022
- VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
- VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
- VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Ongoing Class II Medical devices
- Recall started
- 10 December 2021
- Reason
- The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0735-2022
- VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Ongoing Class II Medical devices
- Recall started
- 22 November 2021
- Reason
- Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0503-2022
- VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Terminated Class III Medical devices
- Recall started
- 15 October 2021
- Terminated
- 18 December 2023
- Reason
- Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
- Distribution
- US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0247-2022
- VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Terminated Class II Medical devices
- Recall started
- 3 May 2021
- Terminated
- 24 October 2023
- Reason
- Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1688-2021
- VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior
Terminated Class II Medical devices
- Recall started
- 26 March 2021
- Terminated
- 24 May 2023
- Reason
- Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, Ind
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1489-2021
- VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Terminated Class II Medical devices
- Recall started
- 18 February 2021
- Terminated
- 18 October 2022
- Reason
- Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1295-2021
- VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668
Terminated Class II Medical devices
- Recall started
- 12 February 2021
- Terminated
- 24 January 2022
- Reason
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Canada L3R 4G5, Chile, Colombia, Denmark, France, Germany, India, Italy, Japan, Portugal, Russia, Singapore 609917, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1267-2021, Z-1266-2021
- VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemilum
- VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SA
Terminated Class II Medical devices
- Recall started
- 14 January 2021
- Terminated
- 27 December 2022
- Reason
- A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1136-2021
- VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuve
Terminated Class II Medical devices
- Recall started
- 20 November 2020
- Terminated
- 24 October 2023
- Reason
- A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0800-2021, Z-0801-2021
- enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Ch
- VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
Terminated Class II Medical devices
- Recall started
- 13 July 2020
- Terminated
- 27 July 2021
- Reason
- Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2875-2020, Z-2873-2020, Z-2874-2020
- VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) co
- VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
- VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and pla
Terminated Class II Medical devices
- Recall started
- 11 May 2020
- Terminated
- 22 September 2021
- Reason
- Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
- Distribution
- Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Oh
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2366-2020, Z-2364-2020, Z-2367-2020, Z-2365-2020
- VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using V
- VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, p
- VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using
- VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plas
Terminated Class II Medical devices
- Recall started
- 1 April 2020
- Terminated
- 19 January 2021
- Reason
- The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1931-2020, Z-1930-2020
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) act
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) a
Terminated Class II Medical devices
- Recall started
- 10 September 2019
- Terminated
- 13 November 2020
- Reason
- Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0268-2020, Z-0269-2020, Z-0267-2020
- VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
- VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
- VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Terminated Class II Medical devices
- Recall started
- 17 June 2019
- Terminated
- 9 November 2020
- Reason
- Potentially Biased Results using VITROS Chemistry Products GLU Slides
- Distribution
- US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2202-2019
- VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/
Terminated Class II Medical devices
- Recall started
- 8 April 2019
- Terminated
- 12 November 2020
- Reason
- Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1936-2019, Z-1933-2019, Z-1935-2019, Z-1934-2019
- VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM
- VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM
- VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include color
- VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (C
Terminated Class II Medical devices
- Recall started
- 20 March 2019
- Terminated
- 8 December 2020
- Reason
- Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1364-2019
- VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measuremen
Terminated Class II Medical devices
- Recall started
- 11 March 2019
- Terminated
- 7 December 2020
- Reason
- One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1222-2019
- VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measu
Terminated Class II Medical devices
- Recall started
- 20 February 2019
- Terminated
- 15 September 2021
- Reason
- Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1289-2019, Z-1292-2019, Z-1287-2019, Z-1288-2019, Z-1293-2019, Z-1291-2019, Z-1290-2019
- VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using
- VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immuno
- VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, us
- VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical in
- VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS I
- VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, us
- VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical int
Terminated Class II Medical devices
- Recall started
- 22 January 2019
- Terminated
- 10 June 2022
- Reason
- Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
- Distribution
- US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0992-2019
- VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5
Terminated Class II Medical devices
- Recall started
- 11 December 2018
- Terminated
- 16 September 2020
- Reason
- Negative bias results when using VITROS VALP Reagent, GEN 25.
- Distribution
- Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0848-2019
- VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,
Ongoing Class II Medical devices
- Recall started
- 1 November 2018
- Reason
- The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
- Distribution
- Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and Uni
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0689-2019, Z-0687-2019, Z-0688-2019
- VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or h
- VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from indivi
- VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms o
Terminated Class II Medical devices
- Recall started
- 19 October 2018
- Terminated
- 24 January 2022
- Reason
- Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0651-2019, Z-0652-2019, Z-0653-2019, Z-0650-2019
- VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum
- VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such
- VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum
- VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product
Terminated Class II Medical devices
- Recall started
- 8 October 2018
- Terminated
- 13 October 2022
- Reason
- VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
- Distribution
- Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0476-2019
- VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Terminated Class II Medical devices
- Recall started
- 28 August 2018
- Terminated
- 11 August 2020
- Reason
- The reagent pack exhibits the potential for an increased frequency of calibration failures.
- Distribution
- Worldwide Distribution: US (nationwide) to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of: Belgium, Bermuda, Brazil, Canada, Chile, Columb
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0392-2019
- VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using
Terminated Class II Medical devices
- Recall started
- 15 August 2018
- Terminated
- 10 January 2022
- Reason
- Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
- Distribution
- Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0080-2019, Z-0079-2019
- VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
- VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
Terminated Class III Medical devices
- Recall started
- 11 July 2018
- Terminated
- 11 August 2020
- Reason
- The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
- Distribution
- Worldwide Distribution - US Nationwide and in the countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3043-2018, Z-3044-2018
- VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasm
- VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and
Terminated Class III Medical devices
- Recall started
- 11 July 2018
- Terminated
- 19 August 2020
- Reason
- The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
- Distribution
- Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3193-2018
- VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure
Terminated Class III Medical devices
- Recall started
- 11 July 2018
- Terminated
- 11 August 2020
- Reason
- The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
- Distribution
- Worldwide Distribution - US Nationwide- The products were distributed to the following foreign countries: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Nether
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3184-2018
- VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chlo
Terminated Class II Medical devices
- Recall started
- 9 May 2018
- Terminated
- 18 August 2020
- Reason
- There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
- Distribution
- Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2344-2018
- VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 5 May 2018
- Terminated
- 19 February 2021
- Reason
- Potential for positively biased results
- Distribution
- US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3280-2018
- VITROS Sodium Slides, Catalog # 837 9034
Terminated Class II Medical devices
- Recall started
- 22 September 2017
- Terminated
- 24 August 2020
- Reason
- This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
- Distribution
- Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0914-2018, Z-0915-2018, Z-0912-2018, Z-0913-2018, Z-0911-2018
- VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
- VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
- VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
- VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
- VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 12 June 2017
- Terminated
- 11 August 2020
- Reason
- The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.
- Distribution
- Worldwide Distribution - US Distribution including Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0273-2018
- VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHY
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.