| Date Initiated by Firm | January 05, 2026 |
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| Date Posted | February 02, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1236-2026 |
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| Recall Event ID |
98268 |
| 510(K)Number | K172944 K183360 K183415 K193567 K211136 |
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| Product Classification |
Susceptibility test cards, antimicrobial - Product Code LTW
|
| Product | 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 |
|---|
| Code Information |
All lot codes of the identified Gram-negative AST test kits. |
| FEI Number |
1950204
|
Recalling Firm/
Manufacturer |
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
|
| For Additional Information Contact | bioMerieux Customer Service Center
800-682-2666 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 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. |
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| Quantity in Commerce | 2,668,954 total |
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| Distribution | Worldwide - US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LTW
|
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