BEUDAMED
    FDA Enforcement Class III Terminated

    Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Recall: Z-1363-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1363-2019
    Event ID
    82590
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 22, 2019
    Initiation Date
    April 9, 2019
    Classification Date
    May 16, 2019
    Termination Date
    December 20, 2019
    Address
    100 Abbott Park Rd Bldg Ap8b, Abbott Park, IL, 60064-3502, United States

    Description

    Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Reason

    Devices were delivered without the required dry ice.

    Code Info

    LN 5P78-11; Lot 18005182

    Distribution

    Distribution to Latvia.

    Quantity

    1 unit