Z-1925-2021 Class II Terminated
FDA device recall Z-1925-2021 was initiated by Pear Therapeutics, Inc. on Jun 7, 2021 and is designated Class II. 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… The recall status is terminated (terminated Jun 14, 2023). Affected quantity: 812 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 30, 2021
- Initiation Date
- Jun 7, 2021
- Termination Date
- Jun 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 812 units
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.
Distribution pattern
U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
Code information
UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1925-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026