{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Germantown",
      "state": "MD",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80404",
      "recalling_firm": "Qiagen Sciences, Inc.",
      "address_1": "19300 Germantown Rd",
      "address_2": "N/A",
      "postal_code": "20874-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution an in the country of , Canada",
      "recall_number": "Z-2577-2018",
      "product_description": "AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA    Product Usage:  Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.",
      "product_quantity": "1620 kits",
      "reason_for_recall": "Potential for control line not appearing on the test strip",
      "recall_initiation_date": "20180518",
      "center_classification_date": "20180808",
      "termination_date": "20200902",
      "report_date": "20180815",
      "code_info": "1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020  2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020"
    }
  ]
}