{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214649",
      "product_res_number": "Z-2162-2025",
      "event_date_initiated": "2025-06-23",
      "event_date_posted": "2025-07-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97142",
      "product_code": "MAQ",
      "pma_numbers": [
        "P160037"
      ],
      "product_description": "BD COR System Software. Model Number: 444829.",
      "code_info": "Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.",
      "firm_fei_number": "1119779",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "city": "Sparks",
      "state": "MD",
      "postal_code": "21152-9212",
      "additional_info_contact": "Jeffrey Zinza\n410-316-4000",
      "reason_for_recall": "Potential for functionality issue that supports the Over\r\nlabeling feature and could lead to possible false negative results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Becton, Dickinson and Company began notification of consignees on about 06/23/2025 via telephone call and followed by a letter.  Consignees were instructed to note the outlined workflows when loading specimens with the Over labeling feature enabled and consider retesting affected specimens for HPV testing if affected.  Consignees were also instructed to post the notification within their facility, notify customers if affected units were further distributed, and complete and return the provided Customer Response Form.",
      "product_quantity": "7 systems",
      "distribution_pattern": "Worldwide - US  Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.",
      "openfda": {
        "pma_number": [
          "P100020",
          "P080014",
          "P160037",
          "P880009",
          "P230003",
          "P190028",
          "P080015",
          "P890064"
        ],
        "registration_number": [
          "2243471",
          "3005406097",
          "1119779",
          "1122376",
          "3003795116",
          "3007420875",
          "3004141078",
          "2028492",
          "9610126",
          "3019837962",
          "3005248192",
          "2134567"
        ],
        "fei_number": [
          "2243471",
          "3005406097",
          "1119779",
          "3003795116",
          "3007420875",
          "3004141078",
          "1000125183",
          "3019837962",
          "3005248192",
          "3003572099",
          "3002622561",
          "3002806559"
        ],
        "device_name": "Kit, Dna Detection, Human Papillomavirus",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}