Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e Recalled by Roche Diagnostics Corporation Due to A software malfunction can occur on the cobas...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
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.
Quantity: 923 instruments
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report