BEUDAMED
    FDA Enforcement Class II Terminated

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    Recall: Z-0857-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0857-2015
    Event ID
    69946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iris Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    December 3, 2014
    Classification Date
    December 23, 2014
    Termination Date
    November 2, 2015
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805, United States

    Description

    RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

    Reason

    Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.

    Code Info

    Serial No. 3100 through 7012

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.

    Quantity

    3912 units