Detect Covid-19 Test Product/Model Number: 21205

Company

Detect Headquarters

Recall Initiated

December 8, 2022

Posted

January 4, 2023

Recall Number

Z-0879-2023

Quantity

10142 (US); 960 OUS

Firm Location

Guilford, CT

Reason for Recall

There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

Distribution

Domestic distribution nationwide. Foreign distribution to Hong Kong.

Lot / Code Info

HY263, HY264, and HB264 Expiration 01JAN2023

Root Cause

Component design/selection

Action Taken

On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line "URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests". Direct customers were notified on December 12, 2022. Customers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect.