{
  "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,
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  },
  "results": [
    {
      "country": "United States",
      "city": "Hazelwood",
      "address_1": "595 Anglum Rd",
      "reason_for_recall": "Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae  to Minocycline.",
      "address_2": "",
      "product_quantity": "337 Kits of 20 Cards/Kit",
      "code_info": "Lot/Serial:  485368220  Expiry:  12-JAN-17",
      "center_classification_date": "20160503",
      "distribution_pattern": "Worldwide Distribution to China \u0013 Taiwan region; No US/military/government distribution.",
      "state": "MO",
      "product_description": "VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712.  VITEK 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. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.",
      "report_date": "20160511",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Biomerieux Inc",
      "recall_number": "Z-1596-2016",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "73585",
      "termination_date": "20170526",
      "more_code_info": "",
      "recall_initiation_date": "20160224",
      "postal_code": "63042-2320",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}