{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waukesha",
      "address_1": "20925 Crossroads Cir Ste 200",
      "reason_for_recall": "Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples.  The variation in reactivity can lead to invalid assays.  If an invalid assay is obtained, those results should not be reported and the test should be re-run.  An invalid assay would not result in significant harm to a pati",
      "address_2": "",
      "product_quantity": "386 kits (370 US, 16 OUS)",
      "code_info": "Kit Lot Number  3000389",
      "center_classification_date": "20130328",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.",
      "state": "WI",
      "product_description": "Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45    GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).",
      "report_date": "20130403",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Genetic Testing Institute,inc",
      "recall_number": "Z-1022-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64501",
      "termination_date": "20160321",
      "more_code_info": "",
      "recall_initiation_date": "20130204",
      "postal_code": "53186-4054",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}