cobas 8000 Modular Analyzer Series — Class II medical device recall Z-0910-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-03-14, distributed nationwide. A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Man
| Recall number | Z-0910-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-07-18 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 245 |
| Serial numbers | 1009-05, 1010-03, 1011-10, 1012-06, 1012-08, 1015-07, 1017-04, 1018-09, 1018-10, 1019-03, 1020-05, 1020-09, 1021-04, 1021-06, 1021-08, 1122-04, 1123-05, 1123-06, 1123-08, 1124-03, 1124-04, 1124-05, 1124-06, 1124-09, 1124-10 and 220 more |
| Model numbers | 05964067001 |
Product
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Reason for recall
A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
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-0910-2018. 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.