{
  "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": "Bedford",
      "address_1": "180 Hartwell Road",
      "reason_for_recall": "Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low",
      "address_2": "",
      "product_quantity": "2171 units",
      "code_info": "Serial Number range: 08010100 through 12062270  Distributed between: Jan 2008 to Jun 2012",
      "center_classification_date": "20120914",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, REPUBLIC OF LUXEMBOURG, MACAU, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA (Slovak Republic), SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED KINGDOM, URUGUAY and VIETNAM.",
      "state": "MA",
      "product_description": "Instrumentation Laboratory ACL TOP 500 CTS\t  PN 0000280040     ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Instrumentation Laboratory Co.",
      "recall_number": "Z-2391-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62894",
      "termination_date": "20151002",
      "more_code_info": "",
      "recall_initiation_date": "20120803",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}