Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 13, 2017
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 for
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 t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diabetes Care, Inc. recalled Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN num… - a moderate-severity action.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN num… was recalled by Roche Diabetes Care, Inc. in December 13, 2017. Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairi…. Check the official notice for the remedy. Verify recall #Z-0197-2018 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. After pairi….
- Moderate
- severity level
- Class II
- classification
- December 13, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0197-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0197-2018) was formally reported on December 13, 2017, with the manufacturer initiating the action on June 8, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diabetes Care, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 1,134 bolus advisor features used.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) and Canada. Distribution scope 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, 3 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
1,134 bolus advisor features used
Related Recalls
6
3 from same agency
Product description
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
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0197-2018 |
| Date reported | December 13, 2017 |
| Date initiated | June 8, 2017 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 1,134 bolus advisor features used |
| Distribution | Worldwide Distribution - US (Nationwide) and Canada |
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-0197-2018) 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 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. Recalled by Roche Diabetes Care, Inc.. Units affected: 1,134 bolus advisor features used.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0197-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0197-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.