{
  "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": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89846",
      "recalling_firm": "NeuMoDx Molecular Inc",
      "address_1": "1250 Eisenhower Pl",
      "address_2": "",
      "postal_code": "48108-3281",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.",
      "recall_number": "Z-1000-2022",
      "product_description": "NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems   with either of the following assays:   NeuMoDx SARS CoV-2 Test Strip (REF 300800)   NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900)  NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection  Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction  Ref. Number: 100100",
      "product_quantity": "773 (72 US and 701 ROW) cases (48 cartridges/case)",
      "reason_for_recall": "Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx\" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx\" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of  patients",
      "recall_initiation_date": "20220218",
      "center_classification_date": "20220422",
      "report_date": "20220504",
      "code_info": "Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431.  GTIN: 10814278020274",
      "more_code_info": ""
    }
  ]
}