{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218083",
      "product_res_number": "Z-1236-2026",
      "event_date_initiated": "2026-01-05",
      "event_date_posted": "2026-02-02",
      "recall_status": "Open, Classified",
      "res_event_number": "98268",
      "product_code": "LTW",
      "k_numbers": [
        "K172944",
        "K183360",
        "K183415",
        "K193567",
        "K211136"
      ],
      "product_description": "VITEK 2 Gram-negative Susceptibility Cards Containing\no\tPolymyxin B (pb02n)\no\tCeftazidime/avibactam (cza02n)\no\tMeropenem/Vaborbactam (mev01n)\no\tImipenem (ipm05n)\no\tImipenem/Relebactam (ipr01n);\n\nCARD NAME/ PRODUCT REFERENCE:\n\nAST-N399  \t423701 \nAST-N402  \t423644 \nAST-N403  \t423645 \nAST-N404  \t423664 \nAST-N405  \t423864 \nAST-N406  \t423869 \nAST-N407  \t423870 \nAST-N409  \t423925 \nAST-N412  \t423936 \nAST-N413  \t423928 \nAST-N414  \t423933 \nAST-N415  \t423934 \nAST-N416  \t423935 \nAST-N417  \t423880 \nAST-N419  \t423948 \nAST-N421  \t424055 \nAST-N428  \t424320 \nAST-N429  \t424321 \nAST-N430  \t424322 \nAST-N433  \t424389 \nAST-N439  \t424501 \nAST-N440  \t424502 \nAST-N443  \t424541 \nAST-N444  \t424587 \nAST-N467  \t424857 \nAST-N476  \t424934 \nAST-N478  \t425052 \nAST-N480 \t425084 \nAST-N481  \t425085 \nAST-N485 \t425182 \nAST-N496 \t425265 \nAST-N800  \t423310 \nAST-N802  \t423706 \nAST-N804  \t424634 \nAST-N808  \t424711 \nAST-N810 \t424712 \nAST-N811  \t424713 \nAST-N813  \t424722 \nAST-N815  \t425054 \nAST-XN09  \t423425 \nAST-XN15  \t423829 \nAST-XN17  \t423673 \nAST-XN18  \t423874 \nAST-XN20  \t423947 \nAST-XN21  \t424197 \nAST-XN22  \t424199 \nAST-XN23  \t424198 \nAST-XN24  \t424351 \nAST-XN26  \t424500 \nAST-XN28  \t424586 \nAST-XN29 \t424604 \nAST-XN30  \t424639 \nAST-XN31 \t424640 \nAST-XN32  \t424678 \nAST-XN33  \t424723 \nAST-XN34  \t424752 \nAST-XN35  \t424810 \nAST-XN36  \t424860 \nAST-XN37  \t424888 \nAST-XN38  \t425074 \nAST-XN39  \t425086 \nAST-XN40  \t425095 \nAST-XN41  \t425204 \nAST-XN42 \t425309 \n\n***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.***\n\nAST-N484 Ref. 425181\nAST-N486 Ref. 425183\nAST-N491 Ref. 425206\nAST-N494 Ref. 425224\nAST-N485 Ref. 425182\nAST-XN41 Ref. 425204\nAST-XN42 Ref. 425309\nAST-N504 Ref. 425491",
      "code_info": "All lot codes of the identified Gram-negative AST test kits.",
      "firm_fei_number": "1950204",
      "recalling_firm": "Biomerieux Inc",
      "address_1": "595 Anglum Rd",
      "city": "Hazelwood",
      "state": "MO",
      "postal_code": "63042-2320",
      "additional_info_contact": "bioMerieux Customer Service Center\n800-682-2666",
      "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.",
      "root_cause_description": "Under Investigation by firm",
      "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.\n\nCustomers can set up a custom bioART rule to trigger when resistant results are obtained for the impacted bug drug combinations above.\n\nBased on individual customer policy, customers may wish to perform retrospective review of resistant results.\n\n***Update***\nOn 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.",
      "product_quantity": "2,668,954 total",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K844231",
          "K853772",
          "K853273",
          "K852613",
          "K853263",
          "K853596",
          "K853686",
          "K853688",
          "K843733",
          "K853689",
          "K853687",
          "K853053",
          "K844159",
          "K853684",
          "K853685",
          "K850347"
        ],
        "pma_number": [
          "N50510"
        ],
        "registration_number": [
          "3025775667",
          "3003750284",
          "8021914",
          "3013718871",
          "2919016",
          "1950204",
          "3009637528",
          "1119779",
          "3009171251",
          "3031977134"
        ],
        "fei_number": [
          "3002806332",
          "3025775667",
          "3003750284",
          "3006759904",
          "3013718871",
          "2919016",
          "1950204",
          "3009637528",
          "1119779",
          "3031977134"
        ],
        "device_name": "Susceptibility Test Cards, Antimicrobial",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}