{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216139",
      "product_res_number": "Z-0441-2026",
      "event_date_initiated": "2025-09-17",
      "event_date_posted": "2025-11-06",
      "recall_status": "Open, Classified",
      "res_event_number": "97628",
      "product_code": "MRR",
      "product_description": "SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706",
      "code_info": "REF: 969706. Lot: M404166. Expiration Date: 30Nov2025",
      "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": "Ian Pilcher\n443-350-6459",
      "reason_for_recall": "Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Beckman Coulter notified consignees via letter on about 09/17/2025. Consignees were instructed to discontinue use of SYNCHRON Systems LDLD reagent lot M404166 and contact Customer Technical Support Center for assistance, review the Safety Data Sheet (SDS) and discard according to laboratory s Standard Operating Procedures and/or your local regulations. The SDS is available at www.beckmancoulter.com.  Additionally, Beckman Coulter recommends sharing the content of this letter with laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the SYNCHRON Systems LDLD reagent lot M404166 to determine if retesting is necessary.",
      "product_quantity": "2,932 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.",
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        "device_name": "System, Test, Low Density, Lipoprotein",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1475",
        "device_class": "1"
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