BEUDAMED
    FDA Recall Terminated

    Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes

    Recall: Z-2169-2011 · Initiated August 18, 2010

    Recall

    Recall Number
    Z-2169-2011
    Event Number
    57446
    Firm
    StatSpin, Inc., dba Iris Sample Processing
    FEI Number
    1221015
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 18, 2010
    Posted
    May 10, 2011
    Terminated
    September 1, 2020
    Address
    60 Glacier Dr, Westwood, MA, 02090-1800

    Description

    Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes

    Reason

    Rotors may fail due to wire spokes breaking

    Action

    Iris notified customers by letter in August 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to install the new rotors and discard the older rotors with the wires. There was no need for customers to return the rotors, but the firm requested customers fax or e-mail the enclosed form to verify that they have installed the new rotors. For any questions customers should call 1-800-782-8774.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia Belgium, Czech Republic, Finland, France, Greece, Kuwait, Norway, Turkey,UK, and Norway.

    Quantity

    2090 units