{
  "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": "2026-04-15",
    "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": "76628",
      "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": "Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI.  Foreign: None",
      "recall_number": "Z-1763-2017",
      "product_description": "Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx",
      "product_quantity": "45 Units",
      "reason_for_recall": "\"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional  reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full.  This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.\"",
      "recall_initiation_date": "20170301",
      "center_classification_date": "20170408",
      "termination_date": "20180703",
      "report_date": "20170419",
      "code_info": "Cobas 8100 bi-directional reformatter (BRF)  module with Software Version 02-xx   Catalog Number: 743995400",
      "more_code_info": ""
    }
  ]
}