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FDADecember 5, 2020device

visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.

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

The hazard

Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.

What to do

FDA enforcement status: Terminated

Brands named

visby medicalvisby

Recall history

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

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visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. — Recall Details · AllClear