c6000 — Class II medical device recall Z-1268-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-04-04, distributed nationwide. Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sampl
| Recall number | Z-1268-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-12-18 |
| Classified | 2018-03-28 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Model numbers | 04745922001, 04745922692, 05036348001, 05036348692, 05860652001 |
Product
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Reason for recall
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
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-1268-2018. 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.