Rochester, NY, United States
Ortho Clinical Diagnostics recalls
15 recalls recorded since 2018, most recently on 10 September 2021. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)3
Terminated or completed12
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 September 2021
- Terminated
- 13 February 2024
- Reason
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results
- Distribution
- Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, P
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0120-2022
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- 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
- 15 December 2020
- Terminated
- 27 July 2021
- Reason
- Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0845-2021, Z-0844-2021
- VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Sys
- VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Co
Ongoing Class II Medical devices
- Recall started
- 11 December 2020
- Reason
- VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0770-2021
- VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase M
Ongoing Class III Medical devices
- Recall started
- 16 October 2020
- Reason
- Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, 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-0471-2021
- VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Ch
Terminated Class II Medical devices
- Recall started
- 30 September 2020
- Terminated
- 7 December 2023
- Reason
- Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore 609917, United Kingdom, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0451-2021, Z-0450-2021
- VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies
- VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Terminated Class II Medical devices
- Recall started
- 20 July 2020
- Terminated
- 18 December 2023
- Reason
- When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
- Distribution
- Worldwide distribution - US Nationwide distribution and the 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, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2879-2020, Z-2878-2020
- VITROS XT7600 Integrated System, Product code 6844461
- VITROS XT3400 Chemistry System, Product code 6844458
Terminated Class II Medical devices
- Recall started
- 17 July 2020
- Terminated
- 16 July 2021
- Reason
- The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2771-2020, Z-2770-2020
- VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization us
- VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use o
Terminated Class II Medical devices
- Recall started
- 20 May 2020
- Terminated
- 16 November 2022
- Reason
- Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
- Distribution
- US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2480-2020, Z-2483-2020, Z-2484-2020, Z-2482-2020, Z-2481-2020
- VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
- VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
- VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
- VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Terminated Class III Medical devices
- Recall started
- 10 March 2020
- Terminated
- 26 September 2022
- Reason
- The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
- Distribution
- US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1834-2020
- VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Terminated Class II Medical devices
- Recall started
- 16 December 2019
- Terminated
- 12 November 2020
- Reason
- Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
- Distribution
- Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1226-2020
- VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+
Terminated Class II Medical devices
- Recall started
- 14 October 2019
- Terminated
- 13 November 2020
- Reason
- Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
- Distribution
- Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0740-2020, Z-0739-2020
- Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600
- 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 56
Terminated Class II Medical devices
- Recall started
- 8 July 2019
- Terminated
- 19 October 2023
- Reason
- Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2179-2019, Z-2175-2019, Z-2174-2019, Z-2184-2019, Z-2178-2019, Z-2183-2019, Z-2176-2019, Z-2181-2019, Z-2182-2019, Z-2177-2019, Z-2180-2019, Z-2185-2019
- VITROS 5600 Integrated System, clinical chemistry analyzer
- VITROS 250 Chemistry System, clinical chemistry analyzer
- VITROS 250 Chemistry System, clinical chemistry analyzer
- VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
- VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
- VITROS 250AT Chemistry System, clinical chemistry analyzer
- VITROS 4600 Chemistry System, clinical chemistry analyzer
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 29 November 2018
- Terminated
- 6 February 2024
- Reason
- A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
- Distribution
- Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, 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-0844-2019
- Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantit
Ongoing Class II Medical devices
- Recall started
- 12 July 2018
- Reason
- The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
- Distribution
- Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0058-2019, Z-0059-2019, Z-0060-2019, Z-0061-2019
- VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
- VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
- VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
- VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Terminated Class III Medical devices
- Recall started
- 10 July 2017
- Terminated
- 6 August 2020
- Reason
- VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0807-2018
- VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control f
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.