{
  "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": "89130",
      "recalling_firm": "Qiagen Sciences LLC",
      "address_1": "19300 Germantown Rd",
      "address_2": "N/A",
      "postal_code": "20874-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.",
      "recall_number": "Z-0455-2022",
      "product_description": "QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223",
      "product_quantity": "376 kits",
      "reason_for_recall": "The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.",
      "recall_initiation_date": "20211108",
      "center_classification_date": "20220105",
      "termination_date": "20230329",
      "report_date": "20220112",
      "code_info": "LOT 210209    UDI (01)14053228038846(17)211127(10)210209(24)691223    Serial Numbers:  412092551   412092559  412092552   412092560  412092553   412092561  412092554   412092563  412092555   412092564  412092556   412092565  412092557   412092566  412092558   412092567"
    }
  ]
}