{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "180309",
      "product_res_number": "Z-1742-2020",
      "event_date_initiated": "2020-03-11",
      "event_date_created": "2020-04-17",
      "recall_status": "Open, Classified",
      "res_event_number": "85209",
      "product_code": "N/A",
      "k_numbers": [
        "K053097"
      ],
      "product_description": "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 susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.",
      "code_info": "VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021",
      "firm_fei_number": "1950204",
      "recalling_firm": "Biomerieux Inc",
      "address_1": "595 Anglum Rd",
      "city": "Hazelwood",
      "state": "MO",
      "postal_code": "63042-2320",
      "reason_for_recall": "There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). \n\n.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On March, 11, 2020 a notification letter was issued to the impacted subsidiaries which included a Customer Letter to be translated into local language. \nThe customer letter instructs the customer to stop the use of the impacted AST-P652 lot, to  complete the attached Acknowledgement Form, and return any affected unused product to their local bioMrieux representative as soon as possible.",
      "product_quantity": "1698 cartons (15,940 cards)",
      "distribution_pattern": "No distribution within the United States. \nForeign distribution locations: Netherlands, Luxembourg, Belgium",
      "openfda": {}
    }
  ]
}