FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
- Recall number
- Z-0675-2018
- Recalling firm
- Roche Diagnostics Corporation
- Product
- Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
- Status
- Terminated
- Initiated
- 2017-07-28
- Posted
- not on file
- Terminated
- 2020-06-10
- Reason
- A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
- Root cause
- Device Design
- Action
- Consignees were notified by letter (receipt required) and requested to follow instructions to determine if the software issue has occurred. If the software issue is detected the consignee contacts customer support to have system reconfigured.
- Quantity
- 399
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K100853"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28