Hazelwood, MO, United States
Biomerieux Inc recalls
39 recalls recorded since 2018, most recently on 24 July 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls39
Ongoing (FDA)12
Terminated or completed27
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 24 July 2026
- Reason
- The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
- Distribution
- International distribution to the countries of Austria, Germany, Luxembourg.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3231-2026
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Ongoing Class II Medical devices
- Recall started
- 4 June 2026
- Reason
- Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2715-2026
- VITEK 2 AST-N447 TEST KIT Product reference 424620
Ongoing Class II Medical devices
- Recall started
- 5 January 2026
- Reason
- Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1236-2026
- VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERE
Ongoing Class II Medical devices
- Recall started
- 26 June 2025
- Reason
- Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
- Distribution
- International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Polan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2671-2025
- VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobi
Ongoing Class I Medical devices
- Recall started
- 14 March 2024
- Reason
- Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1464-2024
- VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 4
Ongoing Class II Medical devices
- Recall started
- 6 February 2023
- Reason
- For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
- Distribution
- US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1201-2023
- MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Ongoing Class II Medical devices
- Recall started
- 9 November 2022
- Reason
- As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0873-2023, Z-0798-2023, Z-0864-2023, Z-0839-2023, Z-0837-2023, Z-0817-2023, Z-0829-2023, Z-0856-2023, Z-0806-2023, Z-0827-2023, Z-0851-2023, Z-0863-2023 and 82 more
- PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
- VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
- VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
- PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
- VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
- ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
- ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
- VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
- and 86 more product lines
Ongoing Class II Medical devices
- Recall started
- 20 July 2022
- Reason
- There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
- Distribution
- Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1564-2022
- NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Ongoing Class II Medical devices
- Recall started
- 13 July 2022
- Reason
- There are 7 reported software anomalies that may affect use of the device.
- Distribution
- International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1640-2022
- VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Ongoing Class II Medical devices
- Recall started
- 29 March 2022
- Reason
- Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
- Distribution
- U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Polan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1059-2022
- VITEK 2 Systems and VITEK 2 with MYLA.
Terminated Class II Medical devices
- Recall started
- 9 February 2022
- Terminated
- 1 April 2026
- Reason
- Invalid calibrations (out of range high) while using the product.
- Distribution
- Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0742-2022
- VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Terminated Class II Medical devices
- Recall started
- 20 December 2021
- Terminated
- 25 September 2023
- Reason
- Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
- Distribution
- US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0525-2022
- API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual ino
Terminated Class II Medical devices
- Recall started
- 9 November 2021
- Terminated
- 10 February 2025
- Reason
- There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0422-2022
- RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Terminated Class II Medical devices
- Recall started
- 30 September 2021
- Terminated
- 18 January 2024
- Reason
- There is potential to provide an incorrect organism identification.
- Distribution
- Distribution in WI, NY, and SD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0243-2022
Ongoing Class II Medical devices
- Recall started
- 22 September 2021
- Reason
- bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0432-2022, Z-0434-2022, Z-0438-2022, Z-0431-2022, Z-0435-2022, Z-0437-2022, Z-0424-2022, Z-0433-2022, Z-0430-2022, Z-0426-2022, Z-0427-2022, Z-0436-2022 and 4 more
- VIDAS RUB IgG (RBG), REF 30226
- VIDAS FSH, REF 30407-01
- VIDAS SARS-COV-2 IgM, Ref 423833-01
- VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
- VIDAS Estradiol II, REF 30431-01
- VIDAS Lyme IgG II (LYM), REF 417401
- VIDAS PRG Progesterone, REF 30409-01
- VIDAS LH, REF 30406-01
- and 8 more product lines
Terminated Class II Medical devices
- Recall started
- 2 September 2021
- Terminated
- 9 March 2026
- Reason
- Under certain conditions, there is a risk for a false negative result.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0084-2022
- MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Terminated Class II Medical devices
- Recall started
- 24 June 2021
- Terminated
- 10 February 2025
- Reason
- Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2226-2021
- ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 22 June 2021
- Terminated
- 6 February 2023
- Reason
- Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
- Distribution
- Distribution in the U.S. was nationwide. There was also military and government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2225-2021
- MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Terminated Class II Medical devices
- Recall started
- 16 March 2021
- Terminated
- 6 August 2024
- Reason
- bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
- Distribution
- Distributed nationwide to NY, CA, IL, WV, NJ, NY, TX, IN, PA, WI, VA, GA, CO, MI, FL, OH, MA, LA, NV, MO, CT and internationally to Argentina, Australia, Belgium, Brazil, Switzerland, Chile, Colombia, Czech Republic, Germany, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1408-2021
Terminated Class II Medical devices
- Recall started
- 28 January 2021
- Terminated
- 12 January 2023
- Reason
- bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK¿ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK¿ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
- Distribution
- Worldwide distribution - No US consignees affected and the countries of Andorra, Austria, Bangladesh, Bermuda, Brazil, Brunei Darussalam, El Salvador, French Guiana, French Polynesia, Gibraltar, Greece, Guadeloupe, Guam, Holy See (Vatican City State), Hong Kong, Hungary, India, Indonesia, Ireland, L
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1308-2021, Z-1307-2021
- VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automat
- VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated syste
Ongoing Class II Medical devices
- Recall started
- 11 March 2020
- Reason
- There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
- Distribution
- No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1742-2020
- The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalac
Terminated Class II Medical devices
- Recall started
- 5 February 2020
- Terminated
- 28 October 2022
- Reason
- The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
- Distribution
- International distribution in the countries of Germany and the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1534-2020
- VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and ye
Terminated Class II Medical devices
- Recall started
- 24 January 2020
- Terminated
- 11 January 2023
- Reason
- The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
- Distribution
- Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1793-2020
- PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year,
Terminated Class II Medical devices
- Recall started
- 10 December 2019
- Terminated
- 16 February 2021
- Reason
- Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
- Distribution
- Distributed nationwide and 9 units to Biomerieux Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1107-2020
- VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Terminated Class II Medical devices
- Recall started
- 22 October 2019
- Terminated
- 6 August 2024
- Reason
- Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0928-2020
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Terminated Class II Medical devices
- Recall started
- 15 March 2019
- Terminated
- 17 August 2021
- Reason
- Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.
- Distribution
- Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1137-2019
- Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Terminated Class II Medical devices
- Recall started
- 13 December 2018
- Terminated
- 16 August 2021
- Reason
- False Positive ESBL Phenotype
- Distribution
- UK and Ireland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0847-2019
- VITEK 2 AST-N351 Test Kit
Terminated Class II Medical devices
- Recall started
- 13 November 2018
- Terminated
- 7 July 2021
- Reason
- The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.
- Distribution
- Nationwide distribution to CO, IL, MO, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0639-2019
- VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Terminated Class II Medical devices
- Recall started
- 22 October 2018
- Terminated
- 4 November 2019
- Reason
- False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY including Puerto Rico and to countries of:Algeria,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0618-2019
- VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The
Terminated Class II Medical devices
- Recall started
- 8 October 2018
- Terminated
- 21 May 2021
- Reason
- Some eluates become colored because of remaining hemoglobin in the eluate.
- Distribution
- CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0443-2019
- bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Terminated Class II Medical devices
- Recall started
- 17 September 2018
- Terminated
- 18 May 2020
- Reason
- Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
- Distribution
- Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0218-2019
- NucliSENS¿ Magnetic Extraction Reagents
Terminated Class II Medical devices
- Recall started
- 13 August 2018
- Terminated
- 2 November 2020
- Reason
- Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
- Distribution
- Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3180-2018, Z-3179-2018
- VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of ins
- VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of ins
Terminated Class II Medical devices
- Recall started
- 27 June 2018
- Terminated
- 21 July 2020
- Reason
- The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KS, LA, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VT, WV. Distributed internationally to Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Germany, Spain, France, Uni
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0229-2019, Z-0230-2019, Z-0228-2019
- BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously mon
- BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuous
- BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously mon
Terminated Class II Medical devices
- Recall started
- 9 April 2018
- Terminated
- 2 December 2025
- Reason
- Invalid calibration with low calibrator S1 while using the product.
- Distribution
- Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2331-2018
- VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked f
Terminated Class II Medical devices
- Recall started
- 23 March 2018
- Terminated
- 23 June 2020
- Reason
- A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
- Distribution
- International distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2167-2018, Z-2166-2018, Z-2169-2018, Z-2164-2018, Z-2165-2018, Z-2168-2018, Z-2172-2018, Z-2170-2018, Z-2171-2018
- The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. a
- The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium sp
- VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using
- The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single
- The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification
- The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative baci
- Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the
- The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PR
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 1 March 2018
- Terminated
- 9 December 2025
- Reason
- Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
- Distribution
- Worldwide Distribution - US Nationwide in the state of Arizona and North Carolina. Distributed internationally to Algeria, Algeria, Angola, Argentina, Bahrain, Bangladesh, Belarus, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Colombia, Congo, Costa Rica, Cote d'Ivoire,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2588-2018
- VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or pl
Terminated Class I Medical devices
- Recall started
- 26 January 2018
- Terminated
- 20 May 2019
- Reason
- Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2817-2018
- bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITE
Terminated Class II Medical devices
- Recall started
- 23 January 2018
- Terminated
- 13 July 2021
- Reason
- Missing desiccant.
- Distribution
- US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2874-2018
- bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Terminated Class II Medical devices
- Recall started
- 4 January 2018
- Terminated
- 14 April 2022
- Reason
- Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY. International distribution to Algeria, Angola, Angu
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2429-2018, Z-2428-2018
- BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and
- BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDA
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.