{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70012",
      "recalling_firm": "Genetic Testing Institute,inc",
      "address_1": "20925 Crossroads Cir Ste 200",
      "address_2": "N/A",
      "postal_code": "53186-4054",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - Nationwide Distribution to the states of : AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN,TX, UT, VA, WA, WV and WI., and the countries of : Canada, Japan, Belgium, European Union , Australia, Taiwan, Thailand and Scotland. ( some countries not yet identified )",
      "recall_number": "Z-1001-2015",
      "product_description": "PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits:  1.  ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and   2.  ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45)    The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The  PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react  with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic  compounds.  The PF4 IgG kit contains all of the reagents necessary to perform  the assay.",
      "product_quantity": "6206 kits",
      "reason_for_recall": "Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.",
      "recall_initiation_date": "20141215",
      "center_classification_date": "20150120",
      "termination_date": "20150430",
      "report_date": "20150128",
      "code_info": "Reagent Lot Numbers:  3001620, 3001987, 3002083, 3002153"
    }
  ]
}