FDA Device recall Z-0754-2021
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module
- FDA Device
- Class II
- ongoing
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module by Roche Diagnostics Operations, citing potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0754-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-08 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
Reason
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Identifiers
| code_info | Serial No. 1017-01 1017-04 1019-09 1019-09 1019-09 1020-01 1022-05 1022-05 1029-09 1029-09 1030-08 1030-09…Serial No. 1017-01 1017-04 1019-09 1019-09 1019-09 1020-01 1022-05 1022-05 1029-09 1029-09 1030-08 1030-09 1030-09 1030-10 1034-09 1036-07 1036-07 1138-03 1138-03 1138-04 1140-09 1140-10 1142-01 1142-02 1142-02 1142-04 1142-04 1142-05 1142-06 1142-08 1142-08 1142-08 1142-09 1142-09 1142-09 1142-10 1143-01 1143-06 1143-09 1143-09 1143-10 1144-01 1146-02 1147-01 1147-03 1147-04 1147-07 1147-09 1149-01 1150-04 1150-05 1150-06 1150-06 1150-06 1150-06 1150-06 1161-05 1161-06 1161-08 1161-08 1161-08 1161-08 1161-08 1163-07 1163-07 1163-07 1163-07 1163-07 1163-10 1163-10 1164-01 1167-06 1167-06 1167-06 1167-07 1167-07 1167-08 1167-08 1167-09 1167-09 1167-10 1167-10 1168-02 1168-02 1168-02 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-04 1168-04 1171-01 1171-01 1171-01 1171-02 1171-05 1206-02 1206-03 1206-04 1206-05 1206-05 1206-06 1206-06 1206-06 1206-06 1206-07 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0754-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.