VISBY MEDICAL product recalled over labeling errors

Recall date

December 5, 2020

Source

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

Official notice title

VISBY MEDICAL INC recalls visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage:…

Recall number

Z-0847-2021

FDA classification

Class II

Brand / firm

VISBY MEDICAL INC

Sold / distributed

U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None

Why it was recalled

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.

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

What was recalled

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.