BEUDAMED
    FDA Recall 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 · Initiated December 3, 2014

    Recall

    Recall Number
    Z-0857-2015
    Event Number
    69946
    Firm
    Iris Diagnostics
    FEI Number
    2023446
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 3, 2014
    Posted
    December 23, 2014
    Terminated
    November 2, 2015
    Address
    9172 Eton Ave, Chatsworth, CA, 91311-5805

    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.

    Action

    A customer notification letter dated 12/3/14 was sent to all customers to inform them that 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. The letter informs the customers of the problems identified and the actions to be taken. Beckman Coulter will be managing the logistics of the recall notice. Customers with questions are instructed to contact Customer Technical Support at (800) 854-3633 or via website at http://www.beckmancoulter.com.

    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