CLASS II Device recall · Reported 19 Dec 2012 · FDA Enforcement Report
DataCara GM is an information management system that recalled
Roche Molecular Systems is recalling DataCara GM is an information management system that provides data management, distributed nationwide in the US. The recall was initiated on 16 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0492-2013
- FDA event ID
- 63312
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2012
- FDA classified
- 7 Dec 2012
- Reported
- 19 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 Jul 2012 | Recall initiated by company | |
| 7 Dec 2012 | Classified by FDA | +144 days |
| 19 Dec 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is DataCara GM is an information management system that provides data management recalled?
Yes. Roche Molecular Systems recalled DataCara GM is an information management system that provides data management on 16 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-0492-2013.
Why was it recalled?
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which lots are affected?
Device-associated diagnostic software
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Insulin Pumps & Glucose Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |