BEUDAMED
    FDA Recall Terminated

    Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    Recall: Z-0451-2007 · Initiated September 20, 2006

    Recall

    Recall Number
    Z-0451-2007
    Event Number
    36728
    Firm
    Drew Scientific Group PLC
    FEI Number
    3003071743
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2006
    Posted
    January 5, 2007
    Terminated
    March 10, 2008
    Address
    4230 Shilling Way, Dallas, TX, 75237-1023

    Description

    Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    Reason

    System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.

    Action

    Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.

    Distribution

    Worldwide distribution ---- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.

    Quantity

    299 units.