Recall Z-1236-2026 · LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
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
| Date | Feb 2, 2026 (initiated Jan 5, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Customers with clinically significant isolates of Enterobacterales species and Pseudomonas aeruginosa with resistant results to Ceftazidime/Avibactam (cza02n), Imipenem (ipm05n), Imipenem/Relebactam (ipr01n), Meropenem/Vaborbactam (mev01n), or Polymyxin B (pb02n) should consider using an alternative method to confirm results. The determination of clinical significance should be made by each laboratory based on the antimicrobial susceptibility profile and the local availability of alternative antibiotics. Customers can set up a custom bioART rule to trigger when resistant results are obtained |
| Quantity | 2,668,954 total |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL bioMerieux, Inc., Dec 19, 2017 |
| K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) bioMerieux, Inc., Feb 26, 2019 |
| K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) bioMerieux, Inc., Feb 20, 2019 |
| K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) bioMerieux, Inc., Feb 14, 2020 |
| K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) bioMerieux, Inc., Jun 14, 2021 |