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Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

Class I - Dangerous
🏥 Medical Devices Recalled: July 28, 2017 Roche Diagnostics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Roche Diagnostics Corporation
Reason for Recall:
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

Product Codes/Lot Numbers:

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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0675-2018

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