BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1925-2021 · Initiated June 7, 2021

    Recall

    Recall Number
    Z-1925-2021
    Event Number
    88061
    Firm
    Pear Therapeutics, Inc.
    FEI Number
    3014109807
    Product Code
    PWE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 7, 2021
    Terminated
    June 14, 2023
    Address
    201 Mission St, Ste 1450, San Francisco, CA, 94105-1882

    Description

    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.

    Action

    On 05/20/2021, the Recalling Firm communicated via email an initial "URGENT: MEDICAL DEVICE RECALL" Notification with an amended/follow-up Notification Letter sent on or about 06/07/2021 informing customers that between 08/10/2020 and 04/30/2021, patients with a urine drug screen (UDS) logged into the Recalling Firm's database 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. Customers are also being informed that there are no actions required for the safe handling of the corrected product. A software release was issued on 04/30/2021 to return the products to their intended operation. Given the potential for reduced clinical effectiveness, Healthcare Providers are encouraged to review patients that have a positive urine drug screen logged to ensure that the patient receives any treatment or counseling necessary to support the patient's treatment. Customers are asked to complete and return the "REPLY FORM" via Fax at 415-458-2700 (Attn: Yuri Maricich) or email to [email protected]. For questions or further assistance, call 1-833-697-3738 (available weekdays 8:00 a.m. - 8:00 p.m. EST)

    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

    812 units