{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "94192",
      "product_res_number": "Z-0136-2011",
      "event_date_initiated": "2010-08-13",
      "event_date_posted": "2010-10-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-23",
      "res_event_number": "56657",
      "product_code": "GKP",
      "k_numbers": [
        "K091980"
      ],
      "product_description": "ACL TOP 500 CTS\nPN  000280040\nBench 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.",
      "code_info": "Serial Number range: 08010100-10061231",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory Co.",
      "address_1": "180 Hartwell Road",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "781-861-4467",
      "reason_for_recall": "Software: New data check, \"Multiple Threshold Check\", was added to identify and fail abnormal (bimodal) clot curves",
      "root_cause_description": "Software design",
      "action": "Instrumentaion Laboratory notified the US Distributor/Canada via BCI Service Modification Notice (#10793) on August 13, 2010. The Mandatory software upgrade to Verison V4.3.0  in the United States and Canada will be conducted by BCI service representatives and tracked through the distributor, Beckman Coulter (BCI). International Affiliates/Dealers:\nWorldwide Regulatory Notices were e-mailed to IL international affiliates and dealers, notifying them of the mandatory software upgrade, providing issue description and a risk summary and the support. The upgrades were to be handled through the local representatives.",
      "product_quantity": "285 units",
      "distribution_pattern": "Worldwide Distribution, USA and Canada",
      "openfda": {
        "k_number": [
          "K885035",
          "K943153",
          "K063679",
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          "K961991",
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          "K921363",
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        "registration_number": [
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        "device_name": "Instrument, Coagulation, Automated",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5400",
        "device_class": "2"
      }
    }
  ]
}