BEUDAMED
    FDA Enforcement Class II Terminated

    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    Recall: Z-2467-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2467-2020
    Event ID
    85634
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    May 11, 2020
    Classification Date
    June 29, 2020
    Termination Date
    February 24, 2023
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    Description

    ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    Reason

    Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.

    Code Info

    All lots

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CA.

    Quantity

    9373 units