BEUDAMED
    FDA Enforcement Class III Terminated

    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

    Recall: Z-0746-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0746-2013
    Event ID
    63918
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    October 22, 2012
    Classification Date
    January 29, 2013
    Termination Date
    September 26, 2013
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997, United States

    Description

    Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

    Reason

    Out of range (increased) HDL Cholesterol results.

    Code Info

    Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.

    Quantity

    11,166 kits