FDA recall Z-1925-2021

Pear Therapeutics, Inc. · Class II · device

Product

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

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

Key facts

Status: Terminated
Initiation date: 2021-06-07
Report date: 2021-06-30
Termination date: 2023-06-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2021