Home / Recalls / Pear Therapeutics, Inc. / Z-1925-2021

Z-1925-2021 Class II Terminated

Recalled by Pear Therapeutics, Inc. — San Francisco, CA

Recall Details

Product Type: Devices
Report Date: June 30, 2021
Initiation Date: June 7, 2021
Termination Date: June 14, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 812 units

Product Description

reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

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 Pattern

U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A

Code Information

UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1