BEUDAMED
    FDA Recall Terminated

    CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.

    Recall: Z-2018-2011 · Initiated March 15, 2011

    Recall

    Recall Number
    Z-2018-2011
    Event Number
    58188
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    March 15, 2011
    Posted
    April 29, 2011
    Terminated
    November 22, 2011
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.

    Reason

    The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

    Action

    Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.

    Distribution

    Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.

    Quantity

    174 total units, all varieties