Roche Recalls cobas e 411 Analyzers Due to Software Malfunction
Roche Diagnostics is recalling 923 cobas e 411 Immunoassay Analyzers because a software malfunction may cause data mismatches in sample and control files.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (data mismatch) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Corporation is recalling 923 cobas e 411 Immunoassay Analyzers. The affected devices include both disk system and rack system models, identified by specific model and catalog numbers listed in the recall documentation. These instruments are fully automated, random access, computer-controlled analytical systems used for quantitative and qualitative determinations of analytes in body fluids.
The recall is being issued because a software malfunction can occur in the Sample & Control data file on the cobas e 411 and Elecsys 2010 analyzers. This malfunction may lead to a potential data mismatch. The agency has classified this recall as Class II.
The affected instruments were distributed nationwide. Users of these devices should contact Roche Diagnostics Corporation for further instructions on how to resolve the software issue.
The recalled product
- 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,
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 923
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- none
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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