BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-0847-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0847-2021
    Event ID
    87049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    VISBY MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 20, 2021
    Initiation Date
    December 5, 2020
    Classification Date
    January 12, 2021
    Termination Date
    January 7, 2022
    Address
    3010 N 1st St, N/A, San Jose, CA, 95134-2023, United States

    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

    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.

    Code Info

    Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)

    Distribution

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

    Quantity

    Total = 282 kits