{
  "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": "78288",
      "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": "worldwide",
      "recall_number": "Z-0074-2018",
      "product_description": "VITEK2 GP-ID, REF 21342 IVD",
      "product_quantity": "5672 cartons",
      "reason_for_recall": "Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM)  in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card.  In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM)  strain is positive.  As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.",
      "recall_initiation_date": "20171011",
      "center_classification_date": "20171108",
      "termination_date": "20201109",
      "report_date": "20171115",
      "code_info": "UDI 03573026131920, Lot Number 2420348103"
    }
  ]
}