{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196119",
      "product_res_number": "Z-0097-2023",
      "event_date_initiated": "2022-09-08",
      "event_date_posted": "2022-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-11-07",
      "res_event_number": "90885",
      "product_code": "NSU",
      "product_description": "cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.",
      "code_info": "Device Identifier: 07613336170076\nAll serial IDs are affected.",
      "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",
      "additional_info_contact": "Roche Support Network Customer Support Center\n800-526-1247",
      "reason_for_recall": "Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On September 8, 2022, the firm notified all affected customers via an Urgent Field Safety Notice letter. Customers were informed that the issue was attributed to WAKO lenses with a deposit on their surfaces, which can affect the signal in the detection unit.\n\nRoche will retrieve and analyze customer's cobas 5800 run data. If the evaluation determines that a lens cleaning is warranted, a service visit will be scheduled. If a lens cleaning is not warranted, no further actions are required.\n\nCustomers should follow laboratory standard operating procedures to investigate the potential for false positive results for assays where a change in result reporting could impact patient management. In the case of testing for respiratory viruses or blood screening, uncovering false positive results more than one week old would be unlikely to change patient management. In the case of assays used to manage chronic diseases (e.g. hepatitis C) or those used in serial monitoring (e.g. HIV), only the most recent result for a patient would have the potential to affect management.\n\nContact your local affiliate organization if there is any allegation of invalid or false positive results with the cobas 5800 system assays.\n\nThis device is not currently available in the US.",
      "product_quantity": "179 OUS",
      "distribution_pattern": "International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.",
      "openfda": {
        "k_number": [
          "K080995",
          "K143178",
          "DEN040012",
          "K082562",
          "K093128",
          "K070597",
          "K073506",
          "K163652",
          "K141220",
          "K121399",
          "K133849",
          "K110786",
          "K133302"
        ],
        "registration_number": [
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        "fei_number": [
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          "3003952975",
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          "2024800",
          "3010770794",
          "3003413192",
          "2243471",
          "3006028115",
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          "3013540184",
          "3008494306",
          "3003423869",
          "2183715",
          "3038610665",
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        ],
        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}