medical Class II Updated 2021-01-20

VISBY MEDICAL INC recalls visby medical COVID-19 Test kit *** An in vitro diagnostic f

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)
View official government recall

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