Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA. On February 15, the agency issued a Class 2 Device Recall for certain software versions of the app due to a bug that could lead users to self-administer inappropriate doses of insulin.
Roche issued an update correcting the bug back in June, and has posted notices on the Accu-Chek website urging users to...
AliveCor recalled Version 2.1.2 of its AliveECG iOS app under an FDA Class III recall according to an FDA posting that went up this month. But in actuality, the "recall," which happened in mid-January, was little more than a run-of-the-mill buggy app update, which the company patched within two days.
"If you read the definitions of recall, if you, as a manufacturer of medical devices, place a...
