Biomerieux Inc Recalls VITEK 2 Gram-negative Susceptibility Cards Due to Potential for False Test Results
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Biomerieux Inc has voluntarily recalled over 2.6 million VITEK 2 Gram-negative Susceptibility Cards due to risks of quality control failures and false resistant antibiotic results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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.
Original source: FDA Official Notice ↗
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