Recall Z-1926-2021— Pear Therapeutics, Inc.

Name: FDA recall Z-1926-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-07

Class II · Terminated

Class II FDA medical device recall by Pear Therapeutics, Inc., initiated 2021-06-07, terminated 2023-06-14. It names one FDA 510(k) clearance: K173681. Product: reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.. Reason: 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..

Recalling firm: Pear Therapeutics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-06-07
Terminated: 2023-06-14
Firm location: San Francisco, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173681 — reSET-OPear Therapeutics, Inc.·cleared 2018-12-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

reSET-O 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.