{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hazelwood",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77935",
      "recalling_firm": "Biomerieux Inc",
      "address_1": "595 Anglum Rd",
      "address_2": "N/A",
      "postal_code": "63042-2320",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US and Angola, Argentina, Austria, Belarus, Belgium, Burkina Faso, Cameroon, Canada, China, Congo, Croatia, Egypt, France, Germany,   Greece, Guam, Hungary, Israel, Italy, Latvia, Luxembourg, Macedonia,   Mali, Mexico, Morocco, Netherlands, Nicaragua, Oman, Panama, Poland,   Saudi Arabia, Serbia, South Africa, South Korea, Spain, Swaziland, Switzerland,   Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom",
      "recall_number": "Z-3134-2017",
      "product_description": "VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc.  VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria",
      "product_quantity": "11,703 cartons",
      "reason_for_recall": "Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM)  in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card.  The expected O129R reaction for ATCC¿ 700327(TM)  strain is positive.",
      "recall_initiation_date": "20170825",
      "center_classification_date": "20170918",
      "termination_date": "20201109",
      "report_date": "20170927",
      "code_info": "Lot Number 2420240403, Exp. 24-JUL-18, 2420303403, Exp 24-SEP-2018",
      "more_code_info": ""
    }
  ]
}