FDA Device recall Z-1449-2014
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitativ…
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitativ… by Roche Diagnostics Operations, citing the Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1449-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-13 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Reason
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
Identifiers
| code_info | not applicable |
|---|
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-1449-2014%22
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