{
  "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": "216039",
      "product_res_number": "Z-0071-2026",
      "event_date_initiated": "2025-09-03",
      "event_date_posted": "2025-10-08",
      "recall_status": "Open, Classified",
      "res_event_number": "97590",
      "product_code": "CEO",
      "product_description": "SYNCHRON Systems Phosphorus (PHOSm) Reagent\nREF: 467868\nFor In Vitro Diagnostic Use, Rx Only.",
      "code_info": "UDI: 15099590233358/ Lot Numbers: M309642\nM309641\nM401490\nM404365\nM406380\nM406417\nM408408\nM410466\nM410513\nM412278",
      "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\n714-961-5321",
      "reason_for_recall": "Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On September 3, 2025, Beckman Coulter issued a \"Urgent Medical Device Recall\" Notification to affected consignees via E-Mail. Beckman Coulter asked consignees to take the following actions:\n\n1. You may continue to use the affected lots if calibration passes and quality control results are within your facility s acceptance criteria.\n\n2. If the above lots fail calibration due to  INIT ADC HI  before the lot expiration date, contact Customer Technical Support Center for troubleshooting and/or replacement.\n\n3.  If you receive replacement product, review the Safety Data Sheet (SDS) and discard the affected lot(s).\n\n4. Beckman Coulter offers SYNCHRON Systems Cartridge Chemistry Phosphorus (PHS REF A09426) Reagent as an alternative. \n\n5. Please share this information with your laboratory staff.  If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter.\n\n6. Please respond within 10 days.",
      "product_quantity": "2146 units",
      "distribution_pattern": "US: AL\tKY\tLA\tMA\tMD\tMS\tNC\tNE\tNJ\tNY\tOK\tPA\tTX\tWA\tWV\nOUS: Canada Mexico Singapore",
      "openfda": {
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        "registration_number": [
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        "fei_number": [
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        "device_name": "Phosphomolybdate (Colorimetric), Inorganic Phosphorus",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1580",
        "device_class": "1"
      }
    }
  ]
}