BEUDAMED
    FDA Recall 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 · Initiated October 8, 2012

    Recall

    Recall Number
    Z-2303-2013
    Event Number
    66108
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 8, 2012
    Posted
    September 30, 2013
    Terminated
    December 24, 2013
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521

    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.

    Action

    On 11/07/2012, the firm sent "Urgent Field Safety Notices to their customers. The product issue was described and recommended actions were provided. Customers may contact 1 (800) 736-0600, option 4 if questions.

    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