BEUDAMED
    FDA Recall Terminated

    StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502

    Recall: Z-0198-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0198-2007
    Event Number
    36459
    Firm
    Iris Sample Processing
    FEI Number
    1221015
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    November 21, 2006
    Terminated
    December 13, 2006
    Address
    60 Glacier Drive, Westwood, MA, 02090-1825

    Description

    StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502

    Reason

    Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.

    Action

    Iris telephoned customers on 9/29/06 and advised them of the recall of the rotor. New rotors were mailed Overnight Confirmed Delivery with instructions for replacement and return of the the old rotor.

    Distribution

    Nationwide

    Quantity

    94 units (Revised on 11/15/06 to 116 units)