BEUDAMED
    FDA Enforcement Class II Ongoing

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    Recall: Z-0104-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0104-2024
    Event ID
    93017
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TECHNO-PATH MANUFACTURING LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 18, 2023
    Initiation Date
    August 25, 2023
    Classification Date
    October 12, 2023
    Address
    Fort Henry Business Park, N/A, Ballina Tipperary, N/A, N/A, Ireland

    Description

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    Reason

    Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.

    Code Info

    a) 08P88-10, UDI/DI 05391523440776, Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, 131112201; b) 08P88-11, UDI/DI 05391523440783, Lot Numbers: 108032102, 110072102, 119112102, 126052202, 130112202, 131112202; c) 08P88-12, UDI/DI 05391523440790, Lot Numbers: 108032103, 110072103, 119112103, 126052203, 130112203, 131112203

    Distribution

    US Nationwide distribution in the state of Illinois.

    Quantity

    117155 units