{
  "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": "2026-04-01",
    "results": {
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  "results": [
    {
      "country": "United States",
      "city": "Bedford",
      "address_1": "180 Hartwell Rd",
      "reason_for_recall": "There is a potential for increased imprecision, out of range quality controls and prolonged sample results.",
      "address_2": "",
      "product_quantity": "9751 kits",
      "code_info": "Lot Number - N0278177  Exp. Date February 28, 2019",
      "center_classification_date": "20181005",
      "distribution_pattern": "US Nationwide",
      "state": "MA",
      "product_description": "Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage -  HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.",
      "report_date": "20181017",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Instrumentation Laboratory Co.",
      "recall_number": "Z-0077-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80932",
      "termination_date": "20190416",
      "more_code_info": "",
      "recall_initiation_date": "20180801",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
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}