{
  "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": [
    {
      "country": "United States",
      "city": "Germantown",
      "address_1": "19300 Germantown Rd",
      "reason_for_recall": "There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.",
      "address_2": "",
      "product_quantity": "1474 kits",
      "code_info": "lots 166020729, 166022794, 166023368, 166023399,  166023400, 166024163, 166024165, 166024166, 166025078, 166025888,  166025889, 166028721, 166028722, 166029506, 166029508",
      "center_classification_date": "20200904",
      "distribution_pattern": "US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.",
      "state": "MD",
      "product_description": "QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.",
      "report_date": "20200916",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Qiagen Sciences LLC",
      "recall_number": "Z-2938-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "86149",
      "termination_date": "20210322",
      "more_code_info": "",
      "recall_initiation_date": "20200715",
      "postal_code": "20874-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}