Biomerieux Inc Recalls VITEK 2 Gram-negative Susceptibility Cards Due to Potential for False Test Results

What Happened

Biomerieux Inc has initiated a voluntary recall of various VITEK 2 Gram-negative Susceptibility Cards. The recall was prompted by the discovery of a potential risk for Quality Control (QC) failures and/or false resistant antibiotic results. This issue occurs when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with specific antibiotic formulations contained within the cards.

Which Products Are Affected

The recall affects a total of 2,668,954 units distributed nationwide across the United States and worldwide. The recall includes all lot codes for the following Gram-negative AST test kits containing Polymyxin B (pb02n), Ceftazidime/avibactam (cza02n), Meropenem/Vaborbactam (mev01n), Imipenem (ipm05n), or Imipenem/Relebactam (ipr01n):

Product Reference Numbers:

• AST-N series: N399 (423701), N402 (423644), N403 (423645), N404 (423664), N405 (423864), N406 (423869), N407 (423870), N409 (423925), N412 (423936), N413 (423928), N414 (423933), N415 (423934), N416 (423935), N417 (423880), N419 (423948), N421 (424055), N428 (424320), N429 (424321), N430 (424322), N433 (424389), N439 (424501), N440 (424502), N443 (424541), N444 (424587), N467 (424857), N476 (424934), N478 (425052), N480 (425084), N481 (425085), N485 (425182), N496 (425265), N800 (423310), N802 (423706), N804 (424634), N808 (424711), N810 (424712), N811 (424713), N813 (424722), N815 (425054)
• AST-XN series: XN09 (423425), XN15 (423829), XN17 (423673), XN18 (423874), XN20 (423947), XN21 (424197), XN22 (424199), XN23 (424198), XN24 (424351), XN26 (424500), XN28 (424586), XN29 (424604), XN30 (424639), XN31 (424640), XN32 (424678), XN33 (424723), XN34 (424752), XN35 (424810), XN36 (424860), XN37 (424888), XN38 (425074), XN39 (425086), XN40 (425095), XN41 (425204), XN42 (425309)

What You Should Do

Biomerieux Inc notified affected customers via letter starting on January 5, 2026. Laboratories and healthcare facilities using these susceptibility cards should review their inventory for the affected reference numbers and follow the specific guidance provided in the firm’s notification letter. For further inquiries, the recalling firm is located at 595 Anglum Rd, Hazelwood, MO 63042.

Why This Matters

This recall is significant because false resistant antibiotic results can lead to incorrect clinical assessments of bacterial infections, potentially resulting in suboptimal treatment for patients. The FDA has classified this as a Class II recall (Recall Number: Z-1236-2026).

Source

Information provided by the FDA.