BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

    Recall: Z-0214-2015 · Initiated September 12, 2014

    Recall

    Recall Number
    Z-0214-2015
    Event Number
    69282
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 12, 2014
    Posted
    November 14, 2014
    Terminated
    July 17, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.

    Reason

    Stability of the ADVIA Centaur Cleaning Solution is not assured

    Action

    Siemens issued an Urgent Medical Device Recall (UMDR) to customers in the US on September 12, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 12, 2014. These notices inform the customer of the degradation of hypochlorite in these lots of cleaning solution. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDR. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall For questions regarding this recall call 508-668-5000.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.

    Quantity

    4645 (12 pk)