BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02

    Recall: Z-0516-06 · Initiated December 23, 2005

    Recall

    Recall Number
    Z-0516-06
    Event Number
    34435
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 23, 2005
    Posted
    February 14, 2006
    Terminated
    April 24, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02

    Reason

    The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.

    Action

    A Device Correction letter identifying the changes being made to the expiration dating for lot numbers 19906M200, 20879MI00 and 26674M1O0 along with a Customer Reply form will be distributed via FedEx to all AEROSET and ARCHITECT c8000 customers which utilize the Clincial Chemistry Multiconstituent Calibrator on December 27,2005. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check.

    Distribution

    Nationwide plus worldwide in Mexico,Venezuela, Chile, Brazil, San Salvador, Singapore, Korea, Trinidad, Grand Cayman, Guatemala, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, Australia, Bermuda, Jamaica, Costa Rica, Ecuador, Argentina, Dominican ReD., Germanv, Thailand, New Zealand, Bahamas, Panama, & Paraguay.

    Quantity

    13961