Pear Therapeutics, Inc. recalls reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

Recall date

June 7, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1926-2021

FDA classification

Class II

Brand / firm

Pear Therapeutics, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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