Roche cobas e 411 Analyzer Software Issue May Cause Data Mismatch
Roche recalls cobas e 411 analyzers due to potential software data mismatch. Affected models include specific part numbers. Users should contact Roche for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Roche is recalling certain cobas e 411 analyzers because a software issue might cause data mismatches. This could lead to inaccurate test results if the device is used without proper correction. Read more at govinfonow.com/recall/73462-roche-cobas-e-411-analyzer-software-issue-may-cause-data.
Source Summary by GovInfoNow · govinfonow.com/recall/73462-roche-cobas-e-411-analyzer-software-issue-may-cause-data · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0498-2018
Cite this page
“Roche cobas e 411 Analyzer Software Issue May Cause Data Mismatch.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73462-roche-cobas-e-411-analyzer-software-issue-may-cause-data. Based on FDA recall #Z-0498-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0498-2018%22&limit=1).
Why it’s dangerous
A software malfunction in the Sample& Control data file can cause the analyzer to produce incorrect test results. This might lead to inaccurate patient data if the device is used without addressing the issue.
Who’s affected
Healthcare facilities using the recalled cobas e 411 analyzers are affected. Laboratory staff and medical professionals who handle these devices are most at risk.
How to tell if you have this one
Check for part numbers 04775279001, 04775279973 (disk system) or 04775201001, 04775201973 (rack system) on the device. The cobas e 411 analyzer is used in medical labs for blood tests.
- Brand
Roche- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0498-2018 | 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.; none | 923 instruments |
| Z-0499-2018 | Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.; none | 255 instruments |
What to do — step by step
Contact Roche
Reach out to Roche Diagnostics Corporation for specific guidance on the recall and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0498-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0498-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.