Recall Z-1925-2021— Pear Therapeutics, Inc.

Name: FDA recall Z-1925-2021
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 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 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.