{
  "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": 3
    }
  },
  "results": [
    {
      "cfres_id": "197993",
      "product_res_number": "Z-1104-2023",
      "event_date_initiated": "2022-12-21",
      "event_date_posted": "2023-02-07",
      "recall_status": "Open, Classified",
      "res_event_number": "91482",
      "product_code": "QLT",
      "product_description": "cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190",
      "code_info": "UDI-DI 00875197006674\nAll in-date lots",
      "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\n800-428-2336",
      "reason_for_recall": "The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.",
      "root_cause_description": "Device Design",
      "action": "On December 22, 2022, Roche posted the Urgent Medical Device Correction (UMDC) to its website (dialog.roche.com).\n\nOn December 27, 2022, the firm also sent UMDC letters to affected customers.\n\nConsignees were instructed to monitor for negative influenza A results that are inconsistent with clinical presentation and/or other clinical and epidemiological information. Authorized or licensed Influenza NAATs are available for confirmation if clinically indicated for at-risk patients. Additionally, consignees are reminded to review the tests  Instructions for Use, specifically the Intended Use Statements and Procedural Limitations sections, which provide guidance on how negative results should be utilized and mutations within the target regions of the tests can impact detection, respectively.\n\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall",
      "product_quantity": "18,071 kits (US); 30,085 kits (OUS)",
      "distribution_pattern": "Domestic distribution nationwide. Foreign distribution worldwide.",
      "openfda": {
        "registration_number": [
          "2243471",
          "3013019728",
          "3014214006",
          "1528450",
          "3017638293",
          "3004141078",
          "3038610665",
          "2024674",
          "2024800"
        ],
        "fei_number": [
          "2243471",
          "3013019728",
          "3014214006",
          "3017638293",
          "3004141078",
          "3038610665",
          "2024674",
          "2024800",
          "1000122536"
        ],
        "device_name": "Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}