BEUDAMED
    FDA Recall Terminated

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    Recall: Z-1977-2014 · Initiated June 6, 2014

    Recall

    Recall Number
    Z-1977-2014
    Event Number
    68490
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 6, 2014
    Posted
    July 2, 2014
    Terminated
    January 27, 2015
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    Reason

    Laser cooling fans and internal fan of the associated fluidics cart are not operational.

    Action

    BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.

    Quantity

    35 installed devices