Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the un…

Recall #: Z-0625-2018
Affected scope: 67,040 unique users of version 2.1.0
Initiated: June 8, 2017

Compiled from official public sources by the publisher. · Updated September 2026

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Roche Diabetes Care, Inc. recalled Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365… - a moderate-severity action.

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365… was recalled by Roche Diabetes Care, Inc. in February 21, 2018. Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a so…. Check the official notice for the remedy. Verify recall #Z-0625-2018 with the FDA Devices before acting.

The recall

Roche Diabetes Care, Inc. issued this moderate-severity FDA Devices recall-Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a so….

Moderate
severity level: Class II
classification: February 21, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0625-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Reason for recall

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0625-2018
Date reported	February 21, 2018
Date initiated	June 8, 2017
Recalling firm	Roche Diabetes Care, Inc.
Firm location	Indianapolis, IN
Affected scope	67,040 unique users of version 2.1.0
Distribution	US Nationwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0625-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017. Recalled by Roche Diabetes Care, Inc.. Units affected: 67,040 unique users of version 2.1.0.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0625-2018.

Where was the recalled product distributed? ▼

Distribution: US Nationwide.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported February 21, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026