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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63803

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
sanofi-aventis US, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.

Z-0609-2013
Recall number
Z-0609-2013
Initiated
September 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
sanofi-aventis US, Inc.
Quantity
1600 downloads (140 US; 1460 Foreign)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

n/a

Distribution pattern

Worldwide distribution.

Field note

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