{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89929",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "address_2": "N/A",
      "postal_code": "27712-9402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. distribution of the FSCA to NC.  OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.",
      "recall_number": "Z-1059-2022",
      "product_description": "VITEK 2 Systems and VITEK 2 with MYLA.",
      "product_quantity": "21,757 systems",
      "reason_for_recall": "Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation.  This can potentially lead to incorrect final screen/synergy test results at the LIS.",
      "recall_initiation_date": "20220329",
      "center_classification_date": "20220511",
      "report_date": "20220518",
      "code_info": "VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2).  VITEK 2 with MYLA - Versions 4.8 and 4.9."
    }
  ]
}