cobas e 411 Immunoassay Analyzer-Model/Catalog/Part recall: Software Issue
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973…
Why was cobas e 411 Immunoassay Analyzer-Model/Catalog/Part 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
none
- Product
- cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 923 instruments
- Distribution
- Nationwide Distribution
- Recall date
- February 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)