{
  "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": "Middletown",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77340",
      "recalling_firm": "Fisher Diagnostics",
      "address_1": "8365 Valley Pike",
      "address_2": "N/A",
      "postal_code": "22645-1905",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA (nationwide) including  Puerto Rico, and Internationally to Colombia",
      "recall_number": "Z-2762-2017",
      "product_description": "Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI  00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.",
      "product_quantity": "331 units",
      "reason_for_recall": "An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199.  While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml.  This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.",
      "recall_initiation_date": "20170519",
      "center_classification_date": "20170725",
      "termination_date": "20180629",
      "report_date": "20170802",
      "code_info": "Lot Number 948546, Exp. 9/30/2017"
    }
  ]
}