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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83761

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

Open FDA event record

Event summary

Timeline bucket
August 29, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LABSTYLE INNOVATIONS

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

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

Z-0260-2020
Recall number
Z-0260-2020
Initiated
August 29, 2019
Classification
Class II
Status
Terminated
Recalling firm
LABSTYLE INNOVATIONS
Quantity
126,271 (83,141 US; 43,130 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

Code information

Android App Software versions 4.3.0-4.3.2

Distribution pattern

Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.