reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Check against the official notice below — it lists the full affected range.
Pear Therapeutics, Inc. is recalling the reSET-O mobile app for iOS and Android devices due to a software issue affecting substance abuse treatment. The app is designed to provide cognitive behavioral therapy and includes a contingency management feature that rewards patients based on urine drug screen results. However, the software malfunction allowed patients who tested positive on urine drug screens to receive access to the reward wheel spin when they should not have been granted that access.
The recall affects approximately 3,370 units of the app distributed across 16 U.S. states: Arizona, California, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Tennessee, Washington, and Wisconsin. The recall notice does not specify what actions affected consumers should take regarding this issue.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
Reason for recall: Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. Distribution: U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A Quantity: 3,370 units Lot/code info: UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.