Detect Headquarters recalls Detect Covid-19 Test Product/Model Number: 21205

Recall date

December 8, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0879-2023

FDA classification

Class II

Brand / firm

Detect Headquarters

Sold / distributed

Domestic distribution nationwide. Foreign distribution to Hong Kong.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Detect Covid-19 Test Product/Model Number: 21205