BEUDAMED
    FDA Recall Terminated

    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).

    Recall: Z-0624-06 · Initiated March 23, 2005

    Recall

    Recall Number
    Z-0624-06
    Event Number
    32890
    Firm
    Abbott Health Products, Inc. Hwy 2 Km 58.0 Cruze Davila
    FEI Number
    2623532
    Product Code
    MGU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2005
    Posted
    March 15, 2006
    Terminated
    January 27, 2012
    Address
    Barceloneta, PR, 00617

    Description

    In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).

    Reason

    Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information regarding the Whole Blood Calibrators and Controls, implementing new internal reference standards was issued.

    Action

    Abbott has recently implemented new internal reference standards for TDx/TDxFLx Cyclosporine monoclonal Whole Blood Calibrators and Controls. A change in performance is associated with the use of calibrator lots 1829Q100 and higher and control lots 18230Q100 and higher, which are the first lots manufactured using the new internal reference standards. The specific performance changes are identified in the letter, dated March 23, 2005, as compared to current product using the previous standards (calibrators lot 05434Q100 and control lot 03071Q100).

    Distribution

    Nationwide, Puerto Rico, Hawaii, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Canada, Germany, Japan , Singapore, India, Taiwan, Thailand, Korea, Australia, Honduras, and Panama,

    Quantity

    4,514 kits were distributed