BEUDAMED
    FDA Enforcement Class III Terminated

    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.

    Recall: Z-0122-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0122-2016
    Event ID
    72120
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2015
    Initiation Date
    August 27, 2015
    Classification Date
    October 15, 2015
    Termination Date
    December 22, 2015
    Address
    9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States

    Description

    Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.

    Reason

    Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.

    Code Info

    Lot C3091 and Lot C3091A

    Distribution

    Nationwide Distribution.

    Quantity

    190 kits