BEUDAMED
    FDA Recall Terminated

    XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10

    Recall: Z-1188-2007 · Initiated May 31, 2007

    Recall

    Recall Number
    Z-1188-2007
    Event Number
    38167
    Firm
    Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
    FEI Number
    2623532
    Product Code
    LGI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 31, 2007
    Posted
    August 22, 2007
    Terminated
    June 10, 2011
    Address
    Barceloneta, PR, 00617-3009

    Description

    XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10

    Reason

    Controls Out of Range/Specification.

    Action

    May 31, 2007, Product Correction Letter to Customers were instructed to: "Revise the expiration date for all lots identified in the customer letter. "Discontinue use of the expired lots, and discard the material according to their laboratory procedures. "An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.

    Distribution

    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS

    Quantity

    93