Biomerieux Inc recalls
Every recall we track for Biomerieux Inc — 151 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Biomerieux Inc peaked in 2022 (98); 151 since 2017. 1% rated “stop using now”.
All FDA recall records for Biomerieux Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 4 | 0 | 4 |
| 2018 | 0 | 0 | 14 | 0 | 14 |
| 2019 | 0 | 1 | 2 | 0 | 3 |
| 2020 | 1 | 0 | 2 | 0 | 3 |
| 2021 | 0 | 0 | 23 | 0 | 23 |
| 2022 | 0 | 0 | 98 | 0 | 98 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
What to do if you have a recalled Biomerieux Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biomerieux Inc recalls
37 shown- Lower riskMedical device
Biomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux recalls VITEK 2 AST-N461 test kits with potential false resistant results, risking ineffective antibiotic treatments. Affected lots produced between specific dates.
BiomerieuxJul 24, 2026 - Lower riskMedical device
Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620
Biomerieux recalls VITEK 2 AST-N447 test kits with pouch foil fractures that may cause false resistance results for carbapenem and cephalosporin tests. This is a US-only product not registered in the US.
BiomerieuxJun 4, 2026 - Lower riskMedical device
Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o
Biomerieux recalls VITEK 2 Gram-negative Susceptibility Cards that may produce false resistant antibiotic results for Enterobacterales and Pseudomonas aeruginosa testing.
BiomerieuxJan 5, 2026 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system
bioMerieux recalls VITEK 2 Gram-negative AST Test Kits with Colistin formulation cs02n that may produce false resistant results for certain bacteria, affecting accurate antibiotic testing.
bioMerieuxJun 26, 2025 - Lower riskMedical device
Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b)
Biomerieux recalls specific VITEK 2 AST test kits (AST-N334, AST-GN95, etc.) due to potential false susceptible results for certain bacteria. Affected kits may mislead antibiotic treatment decisions.
BiomerieuxMar 14, 2024 - Lower riskMedical device
Biomerieux Inc recalls MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments
Biomerieux recalls MYLA software versions 4.7 and : AST filter rules may not apply to results when sending to clinicians. Affected labs should check software version and contact Biomerieux for updates.
BiomerieuxFeb 6, 2023 - Lower riskMedical device
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Biomerieux recalls TSA 10PL: Temperature and time out of range may cause performance issues. Affected units have specific batch numbers and catalog codes.
BiomerieuxNov 9, 2022 - Lower riskMedical device
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica kits (REF 280133) with possible contamination leading to delayed test results. Affected lots expire by December 2022 to January 2023.
bioMerieuxJul 20, 2022 - Lower riskMedical device
bioMerieux, Inc. recalls 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
BioMerieux recalls VITEK 2 software versions 8.01-9.03 and MYLA versions V4.8-V4.9 for 7 reported software anomalies that may affect veterinary use. Affected units have specific UDI/GTIN numbers.
BioMerieuxJul 13, 2022 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.
BioMérieux recalls VITEK 2 Systems and VITEK 2 with MYLA due to software issues causing incorrect antibiotic screen and synergy test results in lab systems. Affected units include specific versions.
BioMérieuxMar 29, 2022 - Lower riskMedical device
bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
BioMérieux recalls VIDAS CMV IgM 30-test kits with invalid calibrations that may cause inaccurate results. Affected lots expire June 2022.
BioMérieuxFeb 9, 2022 - Lower riskMedical device
Biomerieux Inc recalls API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the
Biomer: API ID 32 C Strips (Reference 32200) may have thermoforming defects causing misidentification or delayed results. Recalled due to risk of incorrect yeast identification in lab tests.
BiomerieuxDec 20, 2021 - Lower riskMedical device
Biomerieux Inc recalls RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Biomerieux recalls RAPID 20 E system (lot 1008332150, exp 2022-04-20; lot 1008787180, exp 2022-12-12) due to incorrect color for negative CIT test results in package insert.
BiomerieuxNov 9, 2021 - Lower riskMedical device
bioMerieux, Inc. recalls API 50 CH, Model 50300
Biomerieux recalls API 50 CH Model 50300 due to potential for incorrect organism identification. Affected units include specific lot numbers. Consumers should contact Biomerieux for details.
BiomerieuxSep 30, 2021 - Lower riskMedical device
bioMerieux, Inc. recalls VIDAS RUB IgG (RBG), REF 30226
bioMerieux recalls VIDAS RUB IgG (RBG) tests with specific lot numbers for potential delayed results due to a substrate error that prevents proper testing.
bioMerieuxSep 22, 2021 - Lower riskMedical device
Biomerieux Inc recalls ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Biomerieux recalls ETEST IMIPENEM RELEBACTAM in vitro diagnostics due to false resistant results for Pseudomonas aeruginosa. Affected lots include 1007888860, 1008598340, and others. Stop using if you have these lots.
BiomerieuxJun 24, 2021 - Lower riskMedical device
Biomerieux Inc recalls VIDAS¿ CMV IgM 30 Tests
Biomerieux recalls VIDAS CMV IgM 30 Tests with calibration issues in specific lots. Affected units may give inaccurate results; stop using and contact for replacement.
BiomerieuxMar 16, 2021 - Lower riskMedical device
Biomerieux Inc recalls VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to
Biomerieux recalls VITEK 2 Compact (versions 8.01-9.02) with HL7 configured external communication due to potential false susceptible test results. Lab technicians may need to manually correct LIS results, risking incorrect treatment decisions.
BiomerieuxJan 28, 2021 - Lower riskMedical device
Biomerieux Inc recalls The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as
Biomerieux recalls VITEK 2 Gram-positive Susceptibility Cards (lot 8021232403) due to potential false positive OXSF results for Staphylococcus aureus strains. Affected labs should verify test results with the manufacturer.
BiomerieuxMar 11, 2020 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and
Biomerieux recalls VITEK 2 AST-N371 reagent cards due to compromised pouch seals risking moisture exposure that could affect antibiotic test results. Affected units include specific lot numbers from 2021.
BiomerieuxFeb 5, 2020 - Stop using nowMedical device
bioMerieux, Inc. recalls PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824
bioMerieux recalls PREVI Isola printer power supply units (PSUs) used in Zebra LP2824 printers that may overheat and cause fire. Affected units have specific date codes and instrument serial numbers.
bioMerieuxJan 24, 2020 - Use cautionMedical device
bioMerieux, Inc. recalls VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Biomerieux recalls two batches of VIDAS Varic: Zoster IgG antibody kits due to potential invalid calibration causing delayed results or false positives. Affected kits include US Model 30217-01 Lot 1007410330 and 1007393380.
BiomerieuxDec 10, 2019 - Lower riskMedical device
Biomerieux Inc recalls BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Biomerieux recalls VIDAS 3 compact immunoanalyzer with software versions 1.2+ due to expired calibration causing false test results. Affected units may need recalibration.
BiomerieuxOct 22, 2019 - Lower riskMedical device
bioMerieux, Inc. recalls Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards
Biomerieux recalls specific Vitek 2 test kits for potential ESBL bacteria misidentification risk in lab testing. Affected kits include AST-N254, AST-N330, and AST-N371 models with unique identifiers.
BiomerieuxMar 15, 2019 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK 2 AST-N351 Test Kit
bioMerieux recalls VITEK 2 AST-N35:1 Test Kit (all lots) due to potential false positive ESBL phenotype results. This may lead to incorrect antibiotic treatment decisions. No specific remedy is stated in the recall notice.
bioMerieuxDec 13, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK¿ 2 Systems Software Version 9.01 Update Kit.
bioMerieux recalls VITEK 2 Systems Software Version 9.01 Update Kit due to potential incorrect organism identification and antimicrobial susceptibility testing results when using the FLEXPREP feature.
bioMerieuxNov 13, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog #
bioMerieux recalls VITEK 2 antimicrobial testing products that may show false resistance to Streptococcus anginosus and constellatus strains. Affected items include specific catalog numbers for laboratory use.
bioMerieuxOct 22, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Biomerieux recalls NucliSENS easyMAG Lysis Buffer (ref. 280134) due to potential colored eluates from residual hemoglobin. Affected units were sold with specific lot number and expiration date.
BiomerieuxOct 8, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against
BioMérieux recalls VITEK 2 AST-P655 test cards with insufficient gentamicin due to manufacturing error. Affected lots may produce inaccurate test results for bacterial susceptibility.
BioMérieuxAug 13, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection
Biomerieux recalls BACT/ALERT VIRTUO system B Units with R2.0 firmware due to potential calibration issues. Affected units may show anomalies if calibration standards aren't properly repositioned during service. Contact for remedy details.
BiomerieuxJun 27, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the
BioMérieux recalls VIDAS LH tests with reference numbers 30406 and 30406-01 due to calibration problems using low calibrator S1. Affected lots may show decreased strip signals over time.
BioMérieuxMar 1, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General
bioMerieux recalls VITEK 2 Gram Positive Cefoxitin and Oxacillin test kits due to increased non-detected MRSA cases. Affected kits have specific UDI numbers and are used in lab testing.
bioMerieuxJan 26, 2018 - Lower riskMedical device
Biomerieux Inc recalls bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent
Biomerieux recalls VITEK 2 NH ID Test Kit due to missing desiccant, which may cause reagent degradation. Affected units have batch 2450570: 245057043, expired June 19, 2019.
BiomerieuxJan 23, 2018 - Lower riskMedical device
bioMerieux, Inc. recalls BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS
BioMerieux recalls Quality Control VIDAS (QCV) systems due to pump clogging and label displacement causing inaccurate test results. Affected lab equipment may need replacement to ensure reliable diagnostic testing.
BioMerieuxJan 4, 2018 - Lower riskMedical device
Biomerieux Inc recalls VITEK2 GP-ID, REF 21342 IVD
Biomerieux recalls VITEK2 GP-ID ID cards due to atypical negative reactions for Enterococcus casseliflavus, risking false negative QC test results. Affected lots include specific UDI and lot numbers.
BiomerieuxOct 11, 2017 - Lower riskMedical device
Biomerieux Inc recalls VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of
BioMérieux recalls VITEK 2 GP ID system with specific lot numbers due to atypical negative reactions in Enterococcus casseliflavus QC testing, potentially causing false negative results.
BioMérieuxAug 25, 2017 - Lower riskMedical device
Biomerieux Inc recalls VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent
Biomerieux recalls VITEK 2 Compact 30 software and reagent cards that may stay in preliminary status after ejection, preventing further processing. Affected units were updated to software version 8.01.
BiomerieuxJul 12, 2017
Biomerieux Inc recall questions
How many recalls has Biomerieux Inc had?
151 recalls from Biomerieux Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Biomerieux Inc recall?
Biomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811, dated Jul 24, 2026. Every Biomerieux Inc recall is listed on this page, newest first.
What should I do if I have a recalled Biomerieux Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biomerieux Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.