{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83416",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AZ  CA  FL  HI  IA  IL  IN  KY  LA  MA  MI  MO  MT  NJ  NY  OK  OR  PA  PR  SC  TX  VA",
      "recall_number": "Z-2362-2019",
      "product_description": "Roche Elecsys Anti-CCP Immunoassay  Catalog # 05031656160",
      "product_quantity": "550",
      "reason_for_recall": "Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.",
      "recall_initiation_date": "20190716",
      "center_classification_date": "20190823",
      "termination_date": "20210430",
      "report_date": "20190904",
      "code_info": "Lot # 376808  Exp 08/31/2019  Lot # 389165  Exp 09/30/2019    Anti-CCP assay: Anti-CCP Elecsys cobas e 100    The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019.    ***Updated 7/17/20***  Current (in-date) and future lots of both Catalog numbers are impacted.    In-date lots:  443981, exp. 07/31/2020  457164, exp. 09/30/2020"
    }
  ]
}