FDA (Devices) recall action 88061
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.
Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.