{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184011",
      "product_res_number": "Z-0428-2021",
      "event_date_initiated": "2020-09-25",
      "event_date_created": "2020-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-18",
      "res_event_number": "86550",
      "product_code": "PSZ",
      "product_description": "QUIDEL Sofia SARS Antigen FIA  IVD  REF 20374",
      "code_info": "Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817",
      "firm_fei_number": "2024674",
      "recalling_firm": "Quidel Corporation",
      "address_1": "10165 McKellar Ct",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4201",
      "additional_info_contact": "Ronald H. Lollar\n740-589-3373",
      "reason_for_recall": "Due to false positive results.",
      "root_cause_description": "Process control",
      "action": "On 10/14/2020, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Notification via US Certified mail to customer informing them that a limited number of SARS Antigen FIA test cassettes have an increased potential for false positive results.  Customers are instructed to stop using all product from the affected lot and return the unused product to the Recalling Firm for a replacement or issuance of credit fro any unused product.  The specific instruction to customers are:\n1. Stop using Sofia SARS Antigen FIA, Cat. #20374, Lot 706142.\n2. Return the attached Verification Form with the amount of product that will be returned so a credit may be issued. The customer will be contacted to arrange the return of product and the corresponding credit.\n3. Return any unused product from Sofia SARS Antigen FIA, Cat. #20374, Lot 706142.\n4. In the event that the customer's facility has used this lot number to report patient results, please contact Technical Support at customernotifications@quidel.com. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.",
      "product_quantity": "8,628 kits",
      "distribution_pattern": "U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY",
      "openfda": {
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          "1000119795",
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        ],
        "device_name": "Devices Detecting Influenza A, B, And C Virus Antigens",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3328",
        "device_class": "2"
      }
    }
  ]
}