VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem
FDA device recall Z-1236-2026 · posted 2026-02-02 · Open, Classified
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- 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.
- Action taken
- 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 for the impacted bug drug combinations above. Based on individual customer policy, customers may wish to perform retrospective review of resistant results. ***Update*** On 4/2/26, the firm added additional products to the scope of the recall. The additional product was not manufactured at the time of the original notification, and the additional products are distributed OUS only.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LTW
- Quantity affected
- 2,668,954 total
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2026-01-05
- Date posted
- 2026-02-02
- Location
- Hazelwood, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (K211136) | bioMerieux, Inc. | 2021-06-14 |
| VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) (K193567) | bioMerieux, Inc. | 2020-02-14 |
| VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) (K183360) | bioMerieux, Inc. | 2019-02-26 |
| VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (K183415) | bioMerieux, Inc. | 2019-02-20 |
| VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL (K172944) | bioMerieux, Inc. | 2017-12-19 |