BEUDAMED
    FDA Enforcement Class II Terminated

    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    Recall: Z-2138-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2138-2020
    Event ID
    85390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 3, 2020
    Initiation Date
    November 21, 2019
    Classification Date
    May 28, 2020
    Termination Date
    November 8, 2024
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    Description

    ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    Reason

    The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.

    Code Info

    ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.

    Distribution

    Worldwide distribution - US Nationwide. Also distributed OUS.

    Quantity

    544