BEUDAMED
    FDA Enforcement Class III Terminated

    Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

    Recall: Z-0608-2013 · Reported January 2, 2013

    Enforcement

    Recall Number
    Z-0608-2013
    Event ID
    37530
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2013
    Initiation Date
    June 6, 2006
    Classification Date
    December 21, 2012
    Termination Date
    February 5, 2013
    Address
    810 Sharon Dr, N/A, Westlake, OH, 44145-1598, United States

    Description

    Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

    Reason

    The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.

    Code Info

    Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008.

    Distribution

    Distributed to KY, NC, and NY.

    Quantity

    840 Ampules