{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cypress",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88825",
      "recalling_firm": "DiaSorin Molecular LLC",
      "address_1": "11331 Valley View St",
      "address_2": "N/A",
      "postal_code": "90630-5366",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.",
      "recall_number": "Z-0162-2022",
      "product_description": "SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051",
      "product_quantity": "1690 kits",
      "reason_for_recall": "Due to unapproved raw materials  used in the manufacturing  of Covid-19 control pack, their is the potential for delayed amplification signals.",
      "recall_initiation_date": "20210923",
      "center_classification_date": "20211021",
      "report_date": "20211027",
      "code_info": "Lot #/Expiration Date:  12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022"
    }
  ]
}