{
  "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": "2026-03-18",
    "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": "91504",
      "recalling_firm": "DiaSorin Molecular LLC",
      "address_1": "11331 Valley View St",
      "address_2": "",
      "postal_code": "90630-5366",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.",
      "recall_number": "Z-1209-2023",
      "product_description": "Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2",
      "product_quantity": "90142",
      "reason_for_recall": "Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.",
      "recall_initiation_date": "20230130",
      "center_classification_date": "20230303",
      "report_date": "20230315",
      "code_info": "UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N",
      "more_code_info": ""
    }
  ]
}