reSET 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 its reSET Mobile App available on iOS and Android devices. The app is designed to provide cognitive behavioral therapy as part of substance abuse treatment. A software issue caused the app to grant patients access to a contingency management reward wheel spin regardless of their urine drug screen results. Patients who tested positive should not have been given access to this reward feature.
The recall affects 812 units 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 record does not specify a remedy for affected consumers.
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: 812 units Lot/code info: UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.