{
  "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": "79046",
      "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": "E-Mail",
      "distribution_pattern": "Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.",
      "recall_number": "Z-0675-2018",
      "product_description": "Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001",
      "product_quantity": "399",
      "reason_for_recall": "A software failure may incorrectly set the system settings to \"default\" settings, creating a risk of incorrect results.",
      "recall_initiation_date": "20170728",
      "center_classification_date": "20180221",
      "termination_date": "20200610",
      "report_date": "20180228",
      "code_info": "Serial numbers: 1030-08  1492-06  1492-08  15R9-05  15R9-06  15M9-04  15P2-08  16W0-09  16U1-05  16U1-09  16U1-10  16W4-07  1492-07  1167-07  1167-08  1206-05  1216-18  15F3-07  15H4-06  14A2-06  15F3-04  15F3-05  1015-05  14D2-03  14C9-06  14C9-09  1022-09  1020-01  1022-01  1022-05  1030-10  1029-09  1027-02  1362-01  1350-08  1350-07  1364-04  1364-05  1485-07  1485-08  1498-01  14A2-08  14C6-01  14D1-07  1207-09  15G6-09  15G6-10  15H4-07  1027-04  14C2-04  14C4-05  16Y5-09  16Y5-10  16Y9-07  1031-04  1138-04  15R9-01  15R9-02  1353-03  1344-09  1344-10  1364-08  1372-01  15R9-03  1366-03  1497-10  16Y6-01  16W0-08  14C6-02  15M6-07  15P9-06  15M9-03  15P9-05  16U2-01  16U2-03  16U4-09  16U4-10  16U5-01  16U5-02  16S8-10  16V9-03  16X5-02  16Y3-10  1034-10  1036-07  1138-03  1144-01  1149-01  16X5-05  1017-04  15H5-04  15H5-05  1497-04  1497-03  1142-01  1032-10  16S8-06  16W0-06  1167-10  1332-02  1332-01  1034-09  1214-19  15S3-10  16S8-03  1366-01  1366-02  1214-11  1214-16  16U5-03  16U5-04  1168-02  1168-03  1167-06  1326-17  16Y3-09  16Z2-02  14C9-10  15F3-08  15F3-09  1487-06  1485-09  1140-09  1140-10  1639-01  1492-09  14A2-05  14A2-07  1142-05  1142-06  16S8-08  16S8-09  1372-02  1497-06  1366-08  1475-09  1362-02  1362-03  16Y3-06  1497-05  1147-02  1488-01  1488-02  14D1-09  14D1-10  15H4-03  15P0-02  16S9-04  1142-04  1030-09  1142-02  1143-06  1497-08  15G7-01  15H4-05  15P9-08  15H5-01  15R8-06  15R8-07  1360-02  1360-03  1360-04  1364-06  1364-07  1497-02  16Z2-07  16Y6-04  16Y6-06  1214-20  1215-01  1019-09  1215-17  1326-02  1326-03  1326-19  1326-01  1361-06  1475-08  15H4-01  15P9-07  15R8-01  15R8-04  16U6-01  16U6-02  1350-06  1361-05  1366-06  15M6-10  15S3-08  16U6-04  1326-04  1326-13  1326-14  1326-15  1326-16  15H4-09  15H4-10  16U2-02  16X5-07  1353-02  1372-06  16Y6-02  1345-01  1345-03  1345-04  15R8-05  16U6-03  1351-02  1353-01  15H4-02  15H4-08  1207-07  1325-01  16S8-04  16S8-05  16Y4-01  1206-02  1206-03  1206-04  1206-07  1343-10  1344-07  1344-08  1344-06  15M7-01  15M7-02  16U5-10  16X4-09  16X4-10  16X5-06  1214-17  1214-18  1344-03  1344-04  15H5-02  16S9-01  16X5-08  16X5-09  1326-20  1366-05  16X5-03  1332-03  1332-06  1332-13  1332-14  1332-15  15H6-06  15S3-03  15S3-04  1638-09  16Z2-08  1168-04  1171-02  1215-18  14C6-03  15M9-07  16W0-07  1353-04  1475-10  1326-18  14D5-10  1142-08  1142-09  1167-09  1325-02  1325-03  1345-05  1362-05  14D3-07  14D4-02  16Y8-08  16U2-09  16U2-10  1149-02  16S9-08  1142-10  1143-01  15P9-01  15P9-02  1639-04  1639-02  16Z2-01  14D4-09  14D4-10  1206-01  15M6-06  1146-02  1147-03  1147-04  1161-06  14D2-02  1171-01  1207-08  16U5-09  16Y4-04  16S8-07  16U2-04  15M7-03  15M7-04  15M7-05  15M7-06  16U5-05  16Y4-02  16Y4-03  15P9-03  15P9-04  16S9-05  16Z2-03  16Z2-05  16Y3-04  16Y3-05  1497-07  14C4-06  14C2-03  16X4-07  16X4-08  1171-05  15H5-06  16Y8-10  1161-05  1164-01  1361-09  1361-10  1366-07  1497-01  15L9-09  15M6-09  1161-08  1362-04  1325-14  1325-15  1325-16  15F3-06  1639-03  1147-05  1487-07  1497-09  1147-07  1147-09  16Y3-08  16Y6-05  1344-01  1344-02  1488-07  14A1-10  14D2-01  1163-10  16Z2-09  16Z8-05  15K9-08  16Y3-07  16X5-01  16Y6-10  15P5-03  15P5-04  15P6-03  15R8-08  15R8-09  15R8-10  16S9-02  16S9-03  16U6-05  16U6-06  16U6-07  1364-02  1168-01  1171-06  15P8-09  15P8-10  1143-09  1147-01  1143-10  1332-16  1366-04  1215-20  1206-06  1344-05  1150-04  1150-05  15R9-04  16Y8-05  16Z2-06  16Y8-04  1364-03  1325-13  14D5-02  14D3-08  14D5-01  1150-06  1163-07  16Y8-09  14D6-03  14D6-01  14D6-02  16Y9-01  1639-07  1639-06  15K9-09  15L0-02"
    }
  ]
}