BEUDAMED
    FDA Recall Terminated

    HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box

    Recall: Z-0669-2009 · Initiated September 22, 2008

    Recall

    Recall Number
    Z-0669-2009
    Event Number
    50129
    Firm
    Trek Diagnostic Systems
    FEI Number
    1000515493
    Product Code
    JTZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2008
    Posted
    January 28, 2009
    Terminated
    July 6, 2010
    Address
    982 Keynote Cir, Ste 6, Cleveland, OH, 44131-1873

    Description

    HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box

    Reason

    Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.

    Action

    On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.

    Distribution

    USA distribution in OH and IL.

    Quantity

    4 vials