Detect Covid-19 Test Product/Model Number: 21205
FDA Recall Z-0879-2023 · Posted 2023-01-04
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Recalling FirmDetect Headquarters
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-12-08
Product Quantity10142 (US); 960 OUS
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.
Firm Action
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.
Root Cause
Component design/selection
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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