Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results

The FDA announced on Jan. 5, 2026, that Biomerieux Inc is recalling VITEK 2 Gram-negative Susceptibility Cards due to a potential risk of quality control failures and false resistant antibiotic results. The agency issued the voluntary Class II recall under number Z-1236-2026.

How to tell if you have it

• Brand: Biomerieux
• Product: VITEK 2 Gram-negative Susceptibility Cards
• Antibiotic formulations: Polymyxin B (pb02n), Ceftazidime/avibactam (cza02n), Meropenem/Vaborbactam (mev01n), Imipenem (ipm05n), Imipenem/Relebactam (ipr01n)
• Product References: AST-N399, AST-N402, AST-N403, AST-N404, AST-N405, AST-N406, AST-N407, AST-N409, AST-N412, AST-N413, AST-N414, AST-N415, AST-N416, AST-N417, AST-N419, AST-N421, AST-N428, AST-N429, AST-N430, AST-N433, AST-N439, AST-N440, AST-N443, AST-N444, AST-N467, AST-N476, AST-N478, AST-N480, AST-N481, AST-N485, AST-N496, AST-N800, AST-N802, AST-N804, AST-N808, AST-N810, AST-N811, AST-N813, AST-N815, AST-XN09, AST-XN15, AST-XN17, AST-XN18, AST-XN20, AST-XN21, AST-XN22, AST-XN23, AST-XN24, AST-XN26, AST-XN28, AST-XN29, AST-XN30, AST-XN31, AST-XN32, AST-XN33, AST-XN34, AST-XN35, AST-XN36, AST-XN37, AST-XN38, AST-XN39, AST-XN40, AST-XN41, AST-XN42
• Additional Product References: 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)
• Lot Codes: All lot codes of the identified Gram-negative AST test kits
• Units Affected: 2,668,954 total

The hazard

The recall addresses a 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. The issue may lead to QC failure or false resistant results.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Recent brand recalls include a July 24, 2026 recall for VITEK 2 AST-N461 Test Kits due to false resistant results risk, a June 4, 2026 recall for VITEK 2 AST-N447 Kits regarding false resistance results risk, and a June 26, 2025 recall for VITEK 2 Gram-negative Test Kits that may give false resistant results for Colistin. Other recent recalls of similar products include the HardyDisk AST Cefiderocol 30μg FDC30 recall (June 8, 2026) and the BioFire Respiratory Panel 2.1 Recall (Oct. 22, 2025).