{
  "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": [
    {
      "country": "United States",
      "city": "Bedford",
      "address_1": "180 Hartwell Road",
      "reason_for_recall": "Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No.  0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color.  Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.",
      "address_2": "",
      "product_quantity": "USA: 4088 kits; Foreign: 97,925 kits",
      "code_info": "Lots: N1122175, exp. date 11/30/2014;   N0132936, exp. date 1/31/2015;  N0233302, exp. date 2/28/2015;  N0333382, exp. date 3/31/2015;  E0333382, exp. date 3/31/2015;  N0333626, exp. date 3/31/2015;  N0433932, exp. date 4/30/2015;  N0634953, exp. date 6/30/2015;  N0735317, exp. date 5/31/2015;  N0735599, exp. date 7/31/ 2015;  N0836106, exp. date 8/31/2015;  N0936197, exp. date 9/30/2015;   N0349325, exp. date 12/31/2015;  N1222324, exp. date 12/31/2015;  N0148094, exp. date 12/31/2015;   N0248652, exp. date 2/29/2016;  N0249017, exp. date 2/29/2016;   N0449790, exp. date 4/30/2016;  N0440009, exp. date 4/30/2016.",
      "center_classification_date": "20141219",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.",
      "state": "MA",
      "product_description": "HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company.    A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).",
      "report_date": "20141231",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Instrumentation Laboratory Co.",
      "recall_number": "Z-0832-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69824",
      "termination_date": "20160126",
      "more_code_info": "",
      "recall_initiation_date": "20141121",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}