{
  "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": "Terminated",
      "city": "Germantown",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87047",
      "recalling_firm": "Qiagen Sciences LLC",
      "address_1": "19300 Germantown Rd",
      "address_2": "",
      "postal_code": "20874-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "CA, IN, MI, MN, NC, NJ, NM, OH, TX",
      "recall_number": "Z-0937-2021",
      "product_description": "therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result.    REF 873121",
      "product_quantity": "575 kits US",
      "reason_for_recall": "Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.",
      "recall_initiation_date": "20201211",
      "center_classification_date": "20210128",
      "termination_date": "20220422",
      "report_date": "20210203",
      "code_info": "All  lots",
      "more_code_info": ""
    }
  ]
}