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reSET Mobile App, iOS and Android, provides cognitive… recallZ-1925-2021 · Pear Therapeutics, Inc. · initiated Jun 7, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Pear Therapeutics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Software design

What the company is doing

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)

Recall details

Recall number
Z-1925-2021
Status
Terminated
Initiated by the company
Jun 7, 2021
Recalling firm
Pear Therapeutics, Inc.
Quantity
812 units
Product code
PWE
FDA submissions
K173681
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

Product description

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

Code information (models, lots, serial numbers)

UDI Codes: reSET Mobile App, iOS (01) 10851580008088 (10) 1 reSET Mobile App, Android (01) 10851580008095 (10) 1

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K173681 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88061).

Sources and updates

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