Roche / Hitachi MODULAR Analyzer Systems-Immunoassay recall: Software Issue
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system)…
Why was Roche / Hitachi MODULAR Analyzer Systems-Immunoassay 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
- Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system)…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 255 instruments
- Distribution
- Nationwide Distribution
- Recall date
- February 7, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)