BEUDAMED
    FDA Enforcement Class III Terminated

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    Recall: Z-2778-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2778-2016
    Event ID
    74940
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alere San Diego, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 21, 2016
    Initiation Date
    August 2, 2016
    Classification Date
    September 9, 2016
    Termination Date
    October 28, 2016
    Address
    9975 Summers Ridge Rd, N/A, San Diego, CA, 92121-2997, United States

    Description

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    Reason

    Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

    Code Info

    Model Number: 10-228 and 14-535 Lot Number: 332994

    Distribution

    Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada

    Quantity

    12,951