The COBAS INTEGRA 400/400 plus system recall: Software Issue
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro…
Why was The COBAS INTEGRA 400/400 plus system recalled?
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
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?
Device-associated diagnostic software
- Product
- The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 855 units.
- Distribution
- Nationwide Distribution
- Recall date
- December 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)