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Pear Therapeutics, Inc. recalls reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Recalled June 30, 2021 · FDA recall Z-1926-2021 · Pear Therapeutics
Hazard
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. · FDA Class II
Units
3,370 units
Sold at
U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
Description
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.
Product
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Manufacturer(s)
Pear Therapeutics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →