BEUDAMED
    FDA Enforcement Class II Ongoing

    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

    Recall: Z-0635-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0635-2021
    Event ID
    86774
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 23, 2020
    Initiation Date
    November 9, 2020
    Classification Date
    December 17, 2020
    Address
    1530 Lindbergh Dr, N/A, Beaumont, TX, 77707-4131, United States

    Description

    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

    Reason

    Due to complaints received associated with cracked/split test tube caps.

    Code Info

    Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

    Distribution

    Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.

    Quantity

    Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes