cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number:… — Class II medical device recall Z-0498-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-02-07, distributed nationwide. A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data fil
| Recall number | Z-0498-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-07-05 |
| Classified | 2018-02-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 923 instruments |
| Reason classes | device malfunction, software |
| Model numbers | 04775279001/04775279973 |
Product
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Reason for recall
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
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-0498-2018. 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.