Cobas c8000 Modular Analyzer Series Cobas c502 — Class II medical device recall Z-1449-2014
Terminated recall by Roche Diagnostics Operations, Inc., reported 2014-04-16, distributed nationwide. The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular
| Recall number | Z-1449-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-03-13 |
| Classified | 2014-04-10 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2018-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 76 units |
| Reason classes | labeling |
| Model numbers | 5964067001 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1449-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.