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.
Other recalls by Roche Diagnostics Operations
- cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU,…
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FDA Device · Class II · 2026-01-14 · Roche Diagnostics Operations - cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocystei…
FDA Device · Class II · 2024-11-27 · Roche Diagnostics Operations - Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations - Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
FDA Device · Class II · 2023-11-29 · Roche Diagnostics Operations
All Roche Diagnostics Operations recalls
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.