{
  "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": "85122",
      "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": "E-Mail",
      "distribution_pattern": "Nationwide domestic distribution. Foreign distribution to Canada.",
      "recall_number": "Z-1636-2020",
      "product_description": "AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)",
      "product_quantity": "1654 kit boxes",
      "reason_for_recall": "An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.",
      "recall_initiation_date": "20200221",
      "center_classification_date": "20200401",
      "termination_date": "20201005",
      "report_date": "20200408",
      "code_info": "FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552    FMRT-1-10-US: Lot 563011618    FMRT-1-25-CA: Lot 563011195"
    }
  ]
}