BEUDAMED
    FDA Enforcement Class II Terminated

    AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.

    Recall: Z-1830-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1830-2013
    Event ID
    65576
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Smd Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    May 15, 2013
    Classification Date
    July 30, 2013
    Termination Date
    November 27, 2013
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.

    Reason

    Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.

    Code Info

    The following lots numbers are affected by this recall: 060811, 070111, B11, B11-12/23/2011, B12-02/07/2012, B12-04/30/2012, B12-06/01/2012, B12-08/06/2012, B12-09/05/2012, B12-10/26/2012, and B12-11/27/2012.

    Distribution

    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Internationally to Canada, Japan, Mexico, Chile, and Uruguay.

    Quantity

    11,309 bags