BEUDAMED
    FDA Recall Terminated

    ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.

    Recall: Z-0457-2009 · Initiated September 5, 2008

    Recall

    Recall Number
    Z-0457-2009
    Event Number
    49468
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    JFP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 5, 2008
    Posted
    December 3, 2008
    Terminated
    April 25, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145

    Description

    ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.

    Reason

    The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.

    Action

    On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.

    Distribution

    Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.

    Quantity

    3,200/200ml bottles