DataCara GM is an information management system that recall: Software Issue
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Why was DataCara GM is an information management system that 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
- DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 479 units
- Distribution
- Nationwide Distribution
- Recall date
- December 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)