BEUDAMED
    FDA Recall Terminated

    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    Recall: Z-0191-2012 · Initiated September 21, 2011

    Recall

    Recall Number
    Z-0191-2012
    Event Number
    60174
    Firm
    Caridian BCT, Incorporated
    FEI Number
    1000117351
    Product Code
    LKN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 21, 2011
    Posted
    November 16, 2011
    Terminated
    February 1, 2013
    Address
    10811 W Collins Ave, Lakewood, CO, 80215-4440

    Description

    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    Reason

    Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.

    Action

    CaridianBCT sent a "Safety Alert" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm will be sending a recall letter to consignees in November 2011, stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved. If you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT ( US Toll free 1-877-299-4228 ) or (303) 231-HELP ) ( 1 (303) 231-4357, or your local CaridianBCT Customer Service office.

    Distribution

    Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.

    Quantity

    852 units (US: 333; Foreign: 519)