Z-0847-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- December 5, 2020
- Termination Date
- January 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total = 282 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
Code Information
Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)