BEUDAMED
    FDA Enforcement Class II Terminated

    Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

    Recall: Z-2303-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2303-2013
    Event ID
    66108
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    October 8, 2012
    Classification Date
    September 30, 2013
    Termination Date
    December 24, 2013
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521, United States

    Description

    Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

    Reason

    RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.

    Code Info

    Part Number: 942-066 R1741 to R1869

    Distribution

    Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.

    Quantity

    13,632 boxes/4 membranes