BEUDAMED
    FDA Enforcement Class II Ongoing

    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    Recall: Z-1975-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1975-2023
    Event ID
    92297
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 28, 2023
    Initiation Date
    May 2, 2023
    Classification Date
    June 16, 2023
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131, United States

    Description

    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    Reason

    Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.

    Code Info

    Lot # 3-22, UDI-DI: M5255526870

    Distribution

    Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

    Quantity

    32 units