BEUDAMED
    FDA Recall Terminated

    StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.

    Recall: Z-0807-2010 · Initiated January 27, 2010

    Recall

    Recall Number
    Z-0807-2010
    Event Number
    54365
    Firm
    StatSpin, Inc., dba Iris Sample Processing
    FEI Number
    1221015
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 27, 2010
    Posted
    March 4, 2010
    Terminated
    November 13, 2019
    Address
    60 Glacier Dr, Westwood, MA, 02090-1800

    Description

    StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.

    Reason

    Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.

    Action

    Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.

    Distribution

    Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.

    Quantity

    1510 units