{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197183",
      "product_res_number": "Z-0777-2023",
      "event_date_initiated": "2022-11-18",
      "event_date_posted": "2023-01-03",
      "recall_status": "Open, Classified",
      "res_event_number": "91175",
      "product_code": "JJW",
      "k_numbers": [
        "K072640"
      ],
      "product_description": "BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic\nuse only.",
      "code_info": "UDI/DI 10837461002611, Lot 565-21: 11-30-2022",
      "firm_fei_number": "3000203293",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "11800 Sw 147th Ave",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33196-2500",
      "additional_info_contact": "Ms. Medha Avisetti\n714-686-3113",
      "reason_for_recall": "Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2022 by mail and email.  The notice explained the problem and requested the following actions be taken: \n \"If IRISpec CB controls pass (QC results are within QC acceptance\ncriteria):\nContinue to process patient samples per IFU (P/N 301-7146BE)\nIf IRISpec CB controls fail (QC results are outside QC acceptance\ncriteria):\nRefer to Addendum A below for troubleshooting\nNo retrospective review of QC or patient sample results is necessary.\"  \n\"Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter.\"",
      "product_quantity": "3657 units",
      "distribution_pattern": "US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan",
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        "registration_number": [
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          "3002829675",
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        ],
        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}