{
  "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": "177850",
      "product_res_number": "Z-0669-2020",
      "event_date_initiated": "2019-10-28",
      "event_date_created": "2019-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-06-28",
      "res_event_number": "84260",
      "product_code": "LOL",
      "k_numbers": [
        "K093955"
      ],
      "product_description": "Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma \nCatalog number:  07026773190",
      "code_info": "Anti-HAV IgM APP-file (version 06.05-101)",
      "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": "Roche Customer Support Center\n800-428-2336",
      "reason_for_recall": "Current  software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded\nan erroneous Border Area setting, (1.0   1.00) instead of (0.90   1.10).",
      "root_cause_description": "Employee error",
      "action": "Roche notified  consignees via Urgent Medical Device Correction TP-00811 mailed via UPS Ground (receipt required) on 10/28/19.  Letter states reason for recall, health risk and action to take: Consignee Instructions:\n1. Follow the instructions provided in the Actions to be Taken by\nCustomers/Users Currently Using APP-file Version 06.05-101 section of this\ncommunication. 2. Confirm your cobas e 801 module is using the updated APP-file xx.xx-102 (version 102). If it is not, immediately update to APP-file xx.xx-102 (version 102). 3. If your facility has distributed the affected product to another site, please ensure this Urgent Medical Device Correction (UMDC) is provided to that site. 4. Complete the attached fax form and fax or email it according to the instructions on the form. 5. File this Urgent Medical Device Correction for future use. The UMDC was also posted to the diagnostics.roche.com website. Questions  contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a\nweek at 1-800-428-2336.",
      "product_quantity": "712 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K082049",
          "K082050",
          "K223403",
          "K222850",
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          "K251995",
          "K260048",
          "K092353",
          "K081716",
          "K060678",
          "K243846"
        ],
        "pma_number": [
          "P040018",
          "P780012",
          "P790019",
          "P040017",
          "P890019",
          "P830017",
          "P890014",
          "P830018"
        ],
        "registration_number": [
          "2432235",
          "8023018",
          "2182595",
          "3005360469",
          "3002642396",
          "3008576040",
          "3002809144",
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        ],
        "fei_number": [
          "3003992026",
          "2432235",
          "3005670738",
          "3002806559",
          "2182595",
          "1000206808",
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          "1000136573",
          "3002808212",
          "3004434309",
          "3000308930",
          "3005333358",
          "3012963943"
        ],
        "device_name": "Hepatitis A Test (Antibody And Igm Antibody)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3310",
        "device_class": "2"
      }
    }
  ]
}