CLASS II Device recall · Reported 2 Jan 2013 · FDA Enforcement Report
Diamigo i-Phone App The Diamigo app was intended recalled
sanofi-aventis US is recalling Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the. The recall was initiated on 21 Sep 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-0609-2013
- FDA event ID
- 63803
- Recalling firm
- sanofi-aventis US, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2012
- FDA classified
- 21 Dec 2012
- Reported
- 2 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 21 Sep 2012 | Recall initiated by company | |
| 21 Dec 2012 | Classified by FDA | +91 days |
| 2 Jan 2013 | 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
Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
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
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
Which lots are affected?
n/a
Where was it sold?
Worldwide 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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