FDA-Device2023-01-11Class II
Detect Covid-19 Test Product/Model Number: 21205
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.
Sold states
Domestic distribution nationwide. Foreign distribution to Hong Kong.
Affected count
10142 (US); 960 OUS
Manufactured in
351 New Whitfield St, N/A, Guilford, CT, United States
Products
Detect Covid-19 Test Product/Model Number: 21205
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2023Don't want to check this manually?
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