BEUDAMED
    FDA Recall Terminated

    BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis

    Recall: Z-1940-2010 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-1940-2010
    Event Number
    55654
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 19, 2010
    Posted
    June 30, 2010
    Terminated
    May 18, 2011
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis

    Reason

    Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe

    Action

    The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.

    Distribution

    Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.

    Quantity

    349 units