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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77635

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

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Event summary

Timeline bucket
June 08, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diabetes Care, 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

Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data

Z-0197-2018
Recall number
Z-0197-2018
Initiated
June 08, 2017
Classification
Class II
Status
Terminated
Recalling firm
Roche Diabetes Care, Inc.
Quantity
1,134 bolus advisor features used

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).

Code information

Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.

Distribution pattern

Worldwide Distribution - US (Nationwide) and Canada

Field note

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