Biomerieux, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2010–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• System, Test, Automated, Antimicrobial Susceptibility, Short IncubationLON862
• Monitor, Microbial GrowthJTA55
• Gram Negative Identification PanelLQM42
• System, Blood CulturingMDB41
• Gram Positive Identification PanelLQL20
• FluorometerJZT15
• Susceptibility Test Plate, AntifungalNGZ14
• Instrument, Coagulation, AutomatedGKP13
• Panels, Test, Susceptibility, AntimicrobialLTT9
• Susceptibility Test Cards, AntimicrobialLTW6

Recent recalls

• 2026-07-09Open, ClassifiedProcess change control

  VITEK 2 AST-N447 TEST KIT Product reference 424620

  Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

• 2026-02-02Open, ClassifiedUnder Investigation by firm

  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 REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491

  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.

• 2025-09-29Open, ClassifiedUnder Investigation by firm

  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 antimicrobial susceptibility testing of bacteria and yeast. Export only

  Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

• 2024-04-25Open, ClassifiedEmployee error

  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 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

  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.

• 2023-03-02Open, ClassifiedSoftware design

  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).

  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.

• 2023-01-04Open, ClassifiedStorage

  API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

• 2023-01-04Open, ClassifiedStorage

  API 20 E 25 STRIPS, CATALOG 20100

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

• 2023-01-04Open, ClassifiedStorage

  API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

• 2023-01-04Open, ClassifiedStorage

  API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

• 2023-01-04Open, ClassifiedStorage

  VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed