{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "161501",
      "product_res_number": "Z-0895-2018",
      "event_date_initiated": "2017-08-02",
      "event_date_posted": "2018-03-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-03-29",
      "res_event_number": "79165",
      "product_code": "GJS",
      "k_numbers": [
        "K122584"
      ],
      "product_description": "Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400",
      "code_info": "Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory Co.",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "781-861-4467",
      "reason_for_recall": "Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter.  On  February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to complete a Mandatory Tracking Response form.  For questions contact your Customer Service Representative at 1-800-955-9525, option #1.",
      "product_quantity": "14,894 kits",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "openfda": {
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        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2",
        "registration_number": [
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