{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192098",
      "product_res_number": "Z-0828-2022",
      "event_date_initiated": "2021-11-16",
      "event_date_created": "2022-03-28",
      "recall_status": "Open, Classified",
      "res_event_number": "89643",
      "product_code": "OOI",
      "k_numbers": [
        "K111387"
      ],
      "product_description": "cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190",
      "code_info": "UDI: 07613336100097;\nSerial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086",
      "firm_fei_number": "2243471",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 US Highway 202 S 1080 US Highway 202",
      "city": "S Branchburg",
      "state": "NJ",
      "postal_code": "08876-3733",
      "reason_for_recall": "Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "A Customer Bulletin dated 11/16/21 was sent to customers.\n\nAnalyzer Return Procedure\nOur records indicate that you have one of the affected cobas Liat analyzers listed on the previous page. Because of the issue, Roche will send you a new cobas Liat analyzer.\nPlease return your affected analyzer immediately to Roche for investigation by following the steps below:\n1. A representative from the Roche Support Network Customer Support Center will contact you to initiate analyzer replacement and confirm shipping information.\n2. When you receive the new cobas Liat analyzer from Roche, remove the new analyzer and FedEx shipping label from the box.\n3. Place the affected analyzer in the box and seal it using packing tape.\n4. Affix the FedEx postage paid shipping label to the outside of the box.\n5. Take the box containing the affected analyzer to an appropriate FedEx location for return shipping at no charge to you.\n\nActions Required\n\" Follow the steps in the Analyzer Return Procedure section above.\n\" File this Customer Bulletin for future reference.\n\nPlease contact the Roche Support Network Customer Support Center at 1-800-800-5973 if you have questions about the information in this Customer Bulletin.",
      "product_quantity": "14 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX.  The countries of Cyprus, Spain, and Hong Kong.",
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        "device_name": "Real Time Nucleic Acid Amplification System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}