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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81508

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

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Event summary

Timeline bucket
October 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Voluntis

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

Insulia Diabetes Management Companion

Z-0478-2019
Recall number
Z-0478-2019
Initiated
October 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Voluntis
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.

Code information

Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Distribution pattern

Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall).