FDA-Approved Medical Apps Still Subject to Recall: Roche's Accu-Chek Connect App Withdrawn Shortly After Approval

Apps available in app stores undergo frequent version updates, which are often implemented not only to add new features but also to patch vulnerabilities. However, medical apps require FDA approval before they can be launched on the market. If software vulnerabilities that pose risks to patients emerge during subsequent operations, the issue cannot be resolved simply by releasing an updated version. Instead, these apps may face FDA-mandated recalls and download bans until the vulnerabilities are remediated.

In March this year, Roche received FDA approval for the companion app of its Accu-Chek Connect product, only to recall the app less than a month later. As more apps gain FDA approval, app recalls are becoming increasingly common. App recalls are not as severe as device recalls, as they can typically be addressed quickly through software patches. Based on Jonah Comstock’s report, VCBeat provides a concise overview of the ins and outs of this app recall incident.

This app is currently available only for Android systems. It helps patients track their blood glucose readings and diabetes symptoms, and received FDA approval in mid-March this year. Notably, according to Roche, itIt features the first FDA-approved prescription insulin dose calculator, “Insulin Advisor.”This app provides diabetic patients with reporting options, helping them identify trends and patterns in their blood glucose levels, and enabling them to share their data with caregivers or healthcare teams via online accounts, email, or SMS. It can also receive data from the Bluetooth-enabled Accu-Chek Aviva Connect meter.

During internal testing, Roche discovered thatWhen the app is used in countries such as Germany, South Africa, and Italy, changing the phone’s orientation from portrait to landscape causes calculation deviations, rendering the provided insulin recommendations inaccurate.This is precisely what prompted Roche to issue a recall of the app. According to data provided by the FDA, the app had only been downloaded approximately 600 times in the affected countries prior to the release of the patch.

“The insulin recommendation feature in the app was immediately disabled, and Roche Diabetes Care promptly informed healthcare professionals in affected countries as well as users of the ACCU-CHEK Connect diabetes management app about this issue,” said Roche. “The insulin recommendation feature was re-enabled only after a new version of the app, which fixed the screen rotation issue, was released. In the United States, we did not release the affected ACCU-CHEK Connect diabetes management app.” Roche is currently working with the FDA to obtain approval for the iPhone version of the Accu-Chek Connect companion app.

Similar to Roche’s experience, earlier this year, AliveCor, an ECG monitoring app developed for cardiovascular patients, also had to recall its FDA-cleared app due to a bug that caused crashes. They quickly resolved the issue by releasing an updated version. (For details on the AliveCor case, see:AliveCor: From Medical Device Manufacturing to Data Value Extraction）

According to VCBeat, app recall incidents can be traced back to 2012. Diamigo, a diabetes management app released by Sanofi Pharmaceuticals, is classified as a Class II medical device. Although the app was originally intended solely for the Brazilian market, it was erroneously released globally. The Apple App Store was compelled to issue a notice advising users who had already downloaded the app to refrain from using its insulin calculator and to delete it from their devices.