{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "195034",
      "product_res_number": "Z-1640-2022",
      "event_date_initiated": "2022-07-13",
      "event_date_created": "2022-08-26",
      "recall_status": "Open, Classified",
      "res_event_number": "90605",
      "product_code": "NSX",
      "product_description": "VITEK 2 / MYLA\n\nVITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03\nMYLA Software versions V4.8 and V4.9",
      "code_info": "VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9\n\nUDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914,  03573026619244, 03573026621568",
      "firm_fei_number": "3002769706",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "bioMerieux Customer Service Center\n800-682-2666",
      "reason_for_recall": "There are 7 reported software anomalies that may affect use of the device.",
      "root_cause_description": "Software design",
      "action": "Recall notification was issued on or around July 13, 2022.  Subsidiaries/distributors are instructed to identify/notify any impacted customer(s) in their region(s) of responsibility.  Each customer is requested to return an Acknowledgement Form indicating that they are in receipt of the letter and will comply with the required actions (as appropriate to their laboratory).",
      "distribution_pattern": "International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.",
      "openfda": {
        "registration_number": [
          "3003971136",
          "9611109",
          "1528142",
          "3003587684",
          "3031158",
          "9611031",
          "2024500"
        ],
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          "3002807019",
          "3003587684",
          "3000215024",
          "3002808267",
          "2024500",
          "1000122772"
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      }
    }
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}