{
  "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": "2026-04-08",
    "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": "79526",
      "recalling_firm": "Roche Diagnostics Corporation",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-1519-2018",
      "product_description": "Roche Acetaminophen assay  03255379160-HAcetaminophen (P)  20767174160- cobas c Integra AAcetaminophen150 test",
      "product_quantity": "35,111",
      "reason_for_recall": "The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400  plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following  statement in the Limitations-interference section:  \"In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause  unreliable results.\"",
      "recall_initiation_date": "20180102",
      "center_classification_date": "20180425",
      "termination_date": "20190425",
      "report_date": "20180502",
      "code_info": "Lot codes:  11021500  7/31/2016  12361201  5/31/2017  11031700  9/30/2018  15247301  8/31/2017  11071400  1/31/2016  18036001  11/30/2017  11071600  8/10/2016  19329601  1/31/2018  11101500  1/21/2016  20511301  5/31/2018  11111600  4/30/2018  24076801  8/31/2018  60482201  2/29/2016  60852601  5/31/2016  61385701  9/30/2016  62032101  1/31/2017"
    }
  ]
}