FDA Device recall Z-0492-2013
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data by Roche Molecular Systems, citing roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0492-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Reason
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Identifiers
| code_info | Device-associated diagnostic software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas 5800 instrument, Material No. 08707464001
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All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0492-2013%22
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