BEUDAMED
    FDA Enforcement Class II Ongoing

    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

    Recall: Z-1212-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1212-2023
    Event ID
    91611
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    LetsGetChecked Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 15, 2023
    Initiation Date
    March 16, 2022
    Classification Date
    March 3, 2023
    Address
    1845 Steinway St, Astoria, NY, 11105-1010, United States

    Description

    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

    Reason

    Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

    Code Info

    (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024

    Distribution

    US Nationwide distribution in the state of Alabama.

    Quantity

    50 units