FDA Device recall Z-1792-2014
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat by Roche Diagnostics Operations, citing under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1792-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-21 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Reason
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Identifiers
| code_info | 1125-07 , 1017-06 , 1021-03 , 1021-05 , 1016-05 , 1017-01 , 1124-05 , 1124-06 , 1128-02 , 1132-03 , 1132-04 , 1131-08 ,…1125-07 , 1017-06 , 1021-03 , 1021-05 , 1016-05 , 1017-01 , 1124-05 , 1124-06 , 1128-02 , 1132-03 , 1132-04 , 1131-08 , 1132-01 , 1132-02 , 1128-05 , 1128-06 , 2374-11 , 1132-05 , 1132-10 , 1137-02 , 1139-08 , 1139-10 , 1140-07 , 1140-10 , 1140-08 , 1146-01 , 1146-02 , 1146-03 , 1139-06 , 1139-07 , 1139-09 , 1142-09 , 1145-10 , 1138-10 , 1139-01 , 1127-08 , 1138-08 , 1146-05 , 1146-06 , 1147-04 , 1156-04 , 1140-01 , 1147-05 , 1149-01 , 1149-07 , 1149-08 , 1167-02 , 1156-06 , 1158-09 , 1156-05 , 1158-10 , 1139-02 , 1139-03 , 1139-04 , 1139-05 , 1160-01 , 1160-05 , 1171-07 , 1171-08 , 1171-09 , 1173-10 , 1156-01 , 1160-04 , 1156-07 , 1156-02 , 1156-09 , 1160-06 , 1171-10 , 1173-01 , 1169-06 , 1169-08 , 1169-09 , 1172-09 , 1182-08 , 1211-15 , 1211-14 , 1174-08 , 1160-08 , 1171-06 , 1174-06 , 1174-07 , 1211-13 , 1211-06 , 1183-04 , 1217-09 , 1225-11 , 1211-16 , 1211-17 , 1211-18 , 1224-10 , 1156-08 , 1156-10 , 1225-14 , 1331-13 , 1338-15 , 1338-16 , 1211-19 , 1211-04 , 1211-05 , 1211-20 , |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1792-2014%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.