{
  "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": "210764",
      "product_res_number": "Z-0489-2025",
      "event_date_initiated": "2024-10-17",
      "event_date_posted": "2024-11-19",
      "recall_status": "Open, Classified",
      "res_event_number": "95609",
      "product_code": "LPS",
      "k_numbers": [
        "K113793"
      ],
      "product_description": "cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine",
      "code_info": "UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "317-521-4343",
      "reason_for_recall": "Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)",
      "root_cause_description": "Under Investigation by firm",
      "action": "Roche issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/17/2024 via UPS Ground.  The notice explained the issue, clinical significance, and requested the following actions be taken:  \n\"\" HCYS kits lot number 747029 expired on September 30, 2024. Ensure any inventory you have of this lot has been discarded per your local guidelines.\n\" Follow your laboratory s standard operating procedures to determine specific clinical implications for your patients and whether retrospective review of patient results is required.  \n\" Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients.  \n\" If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site.\"  \nFor questions:  contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336",
      "product_quantity": "458 units",
      "distribution_pattern": "US:  NJ, TX, NY, FL, IN, TX, OK, SC, IA,",
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        "fei_number": [
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        "device_name": "Urinary Homocystine (Nonquantitative) Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1377",
        "device_class": "2"
      }
    }
  ]
}