FDADecember 8, 2022device

Detect Covid-19 Test Product/Model Number: 21205

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

detect headquartersdetect

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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