FDA Device recall Z-0168-2014
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas by Roche Diagnostics Operations, citing roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0168-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-16 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Reason
Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
Identifiers
| code_info | software version 9864.C2 |
|---|
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-0168-2014%22
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