reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Reported: June 30, 2021 Initiated: June 7, 2021 #Z-1925-2021
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.
Details
- Recalling Firm
- Pear Therapeutics, Inc.
- Units Affected
- 812 units
- 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
- Location
- San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.. Recalled by Pear Therapeutics, Inc.. Units affected: 812 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1925-2021.
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