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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1926-2021
Event ID88061
Event DescriptionreSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Product TypeDevices
DistributionU.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
Quantity3,370 units
Recall ReasonDue 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 Classification20210630
Device Code InfoUDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1
Center Classification Date20210621
Recall Initiation Date20210607
Recalling FirmPear Therapeutics, Inc.
Initial Notification Letter
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