FDA Device recall Z-0910-2018
cobas 8000 Modular Analyzer Series
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of cobas 8000 Modular Analyzer Series by Roche Diagnostics, citing A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0910-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-18 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Reason
A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
Identifiers
| code_info | Serial Numbers: 16C4-09 1475-01 1476-05 15A1-03 15A1-05 16B3-10 1474-06 1138-10 1140-10 1485-06 1590-01 1475…Serial Numbers: 16C4-09 1475-01 1476-05 15A1-03 15A1-05 16B3-10 1474-06 1138-10 1140-10 1485-06 1590-01 1475-05 1484-05 1484-06 1012-06 1482-02 1481-10 1254-07 1487-07 1482-09 1482-10 16B7-08 16B8-06 1010-03 1020-09 15A2-02 1247-02 1267-06 15A2-03 1267-01 1369-02 16B5-08 16B3-03 15A5-04 15A5-03 1124-03 1125-04 1591-04 1591-05 1474-09 1474-08 1009-05 1021-08 1139-03 1140-09 1267-02 1267-03 1140-06 16B1-02 16B1-03 1138-04 1138-09 16B4-03 16C3-03 1485-07 1597-09 1011-10 1018-10 16C7-08 16C4-07 1475-02 1475-04 1476-07 16C4-10 16C5-10 15A4-04 15A4-05 1267-07 1474-07 1266-08 1267-09 1256-02 1256-03 1125-05 1369-08 15A6-04 15A7-03 1020-05 1124-04 1123-08 1485-09 1597-04 15A0-03 16C1-05 16C1-06 16C1-07 1267-08 1594-02 1594-04 1594-05 1594-06 1595-01 1595-06 1597-02 1597-03 15A3-01 15A4-01 16B0-02 16B0-03 16B0-04 16B8-03 16B8-04 16B5-09 16B8-01 16B2-07 16B2-08 1266-06 1266-07 1591-01 159 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0910-2018%22
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