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Detect Headquarters recalls Detect Covid-19 Test Product/Model Number: 21205
Recalled January 11, 2023 · FDA recall Z-0879-2023 · Detect Headquarters
Hazard
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. · FDA Class II
Units
10142 (US); 960 OUS
Sold at
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Description
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.
Product
Detect Covid-19 Test Product/Model Number: 21205
Manufacturer(s)
Detect Headquarters
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →