{
  "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": "175792",
      "product_res_number": "Z-0210-2020",
      "event_date_initiated": "2018-08-24",
      "event_date_created": "2019-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-08-02",
      "res_event_number": "83583",
      "product_code": "CDT",
      "product_description": "Beckman Coulter Lipase, REF OSR6130 and OSR6230.",
      "code_info": "All lots",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "800-223-0130",
      "reason_for_recall": "NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The recalling firm issued letters dated 8/21/2018 via email or postal mail if an email address was not available on 8/24/2018 to their customers.  The letter identified the affected product, problem and actions to be taken.  For questions call 1-800-223-0139 in the United States and Canada.  Outside the United States and Canada contact local Beckman Coulter Representative.",
      "product_quantity": "20,926 units",
      "distribution_pattern": "Distribution was nationwide.  There was government and military distribution.  Foreign distribution was made to Canada.",
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        "device_name": "Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1705",
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      }
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}