BEUDAMED
    FDA Recall 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 · Initiated May 15, 2013

    Recall

    Recall Number
    Z-1830-2013
    Event Number
    65576
    Firm
    Tosoh Smd Inc
    FEI Number
    3005529799
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 15, 2013
    Posted
    July 30, 2013
    Terminated
    November 27, 2013
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    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.

    Action

    Tosoh Bioscience sent an Urgent Recall Notification letter dated May 15, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to respond on the amount of product that was destroyed by completing the attached form and faxing it to 614-317-1941. Customers with questions were instructed to call Tosoh Technical Support at 1-800-248-6764. For questions regarding this recall call 614-317-1909.

    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