BEUDAMED
    FDA Recall Terminated

    Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.

    Recall: Z-2287-2008 · Initiated April 21, 2008

    Recall

    Recall Number
    Z-2287-2008
    Event Number
    48709
    Firm
    Abaxis Inc
    FEI Number
    2939693
    Product Code
    JLB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 21, 2008
    Posted
    September 17, 2008
    Terminated
    April 26, 2011
    Address
    3240 Whipple Rd, Union City, CA, 94587

    Description

    Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent disk intended for use with the Piccolo and PiccoloXpress chemistry analyzers, for in vitro qualitative determination.

    Reason

    The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples

    Action

    The firm issued a notification letter to its consignees on April 21, 2008. The firm intends to follow up with phone calls and provide a software upgrade for the products. Contact Abaxis Customer Service at 1-510-675-6500 for assistance.

    Distribution

    Product was distributed Worldwide.

    Quantity

    237 kits