Detect Headquarters Detect Covid-19 Test Product/Model Number: 21205 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Detect Covid-19 Test Product/Model Number: 21205
Brand
Detect Headquarters
Lot Codes / Batch Numbers
HY263, HY264, and HB264 Expiration 01JAN2023
Products Sold
HY263, HY264, and HB264 Expiration 01JAN2023
Detect Headquarters is recalling Detect Covid-19 Test Product/Model Number: 21205 due to There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026