{
  "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": "89098",
      "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": "US:  AZ,  CA,  CO,  CT,  DC,  FL,  GA,  HI,  IA,  IL,  IN,  KS,  KY,  LA,  MA,  MD,  ME,  MI,  MN,  MO,  NC,  ND,  NE,  NH,  NJ,  NM,  NV,  NY,  OH,  PA,  RI,  SC,  SD,  TN,  TX,  VA,  VT,  WA,  WI,  WV; and      Worldwide:  Kuwait,  Australia,  Israel,  Italy,  Canada,  Chile,  Puerto Rico,  United Arab Emirates.",
      "recall_number": "Z-0457-2022",
      "product_description": "Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455",
      "product_quantity": "29495 kits",
      "reason_for_recall": "A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.",
      "recall_initiation_date": "20211119",
      "center_classification_date": "20220105",
      "report_date": "20220112",
      "code_info": "Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers):    12410N (12152N),  12411N (12147N),  12413N (12149N),  12477N (12150N),  12602N (11548NA),  12603N (12144N),  12721N (12148N),  12889N (12151N),  13369N (12817N),  13370N (13151N),  13434N (12382N),  13652N (12835N), and  13242N (12154N)*.    *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US."
    }
  ]
}