Pear Therapeutics, Inc. Recall 88061
Description: reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Pear Therapeutics, Inc. Recall 88061 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1926-2021 |
| Event ID | 88061 |
| Event Description | reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20210630 |
| Device Code Info | UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1 |
| Center Classification Date | 20210621 |
| Recall Initiation Date | 20210607 |
| Recalling Firm | Pear Therapeutics, Inc. |
| Initial Notification | Letter |
| Similar To |