cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product… — Class II medical device recall Z-0095-2017
Terminated recall by Roche Diagnostics Operations, Inc., reported 2016-11-02, distributed nationwide. Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers s
| Recall number | Z-0095-2017 |
|---|---|
| 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 | 2016-07-15 |
| Classified | 2016-10-25 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 9,014 in |
Product
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.
Reason for recall
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
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-0095-2017. 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.