{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190052",
      "product_res_number": "Z-0276-2022",
      "event_date_initiated": "2021-10-13",
      "event_date_posted": "2021-11-23",
      "recall_status": "Open, Classified",
      "res_event_number": "88930",
      "product_code": "GJS",
      "k_numbers": [
        "K122584"
      ],
      "product_description": "HemosIL ReadiPlasTin (20 mL), Part number 0020301400.  An in vitro diagnostic thromboplastin reagent.",
      "code_info": "Lot N0705526   \n\nUDI: 08426950632887  \n\n***Updated 3/3/22***  \n\nFirm has expanded recall to include the following lot:  \n\nN0806224",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "IL Technical Support Center\n800-678-0710",
      "reason_for_recall": "The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On October 13, 2021, the firm sent customers Urgent Medical Device Removal letters via email. These emails were followed by certified letters sent starting the same day.\n\n***On February 17, 2022, the firm expanded the recall to include an additional lot of product.***\n\nThe customers were provided with instructions to run quality controls with each vial. Customers should discard any vials with failed quality controls.\n\nFor technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products).\n\nFor alternate lot availability questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 0.",
      "product_quantity": "5828 kits (310 US)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.",
      "openfda": {
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          "K903019",
          "K093460",
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          "K122584",
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          "K955843",
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          "K864392",
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          "K012768",
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          "K830331",
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          "K864283",
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          "K864272",
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          "K904325",
          "K180780",
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          "K170960",
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          "K022922",
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          "K020840",
          "K060931",
          "K010599",
          "K070005",
          "K213426",
          "K952608",
          "K913250",
          "K994006",
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          "K994100",
          "K110212",
          "K882456",
          "K092940",
          "K021190",
          "K092987",
          "K961835",
          "K922565",
          "K864273",
          "K992492",
          "K935748",
          "K071041",
          "K940432",
          "K972866",
          "K052124",
          "K230802",
          "K151964",
          "K040296",
          "K201185",
          "K072727",
          "K220282",
          "K243543",
          "K874592",
          "K905857",
          "K911995",
          "K253188",
          "K885107",
          "K020355",
          "K864274",
          "K870596",
          "K132722",
          "K940082",
          "K891370",
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          "K891169",
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          "K810350",
          "K935702",
          "K851125",
          "K925492",
          "K922040",
          "K251564",
          "K843535"
        ],
        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2",
        "registration_number": [
          "3005643513",
          "3015499222",
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        "fei_number": [
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}