BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1926-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1926-2021
    Event ID
    88061
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pear Therapeutics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 30, 2021
    Initiation Date
    June 7, 2021
    Classification Date
    June 21, 2021
    Termination Date
    June 14, 2023
    Address
    201 Mission St Ste 1450, N/A, San Francisco, CA, 94105-1882, United States

    Description

    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.

    Code Info

    UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1

    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

    Quantity

    3,370 units