BEUDAMED
    FDA Recall Terminated

    BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

    Recall: Z-1007-2010 · Initiated January 29, 2009

    Recall

    Recall Number
    Z-1007-2010
    Event Number
    51256
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 29, 2009
    Posted
    April 16, 2010
    Terminated
    March 8, 2011
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.

    Reason

    The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.

    Action

    On 1/29/09, the firm initiated the recall and its notification was via Important Product Information letters identifying the affected product and explaining the reason for the recall. Customers who experienced error codes with the affected product were to contact their local BD Biosciences representative or distributor to receive replacement BD FACSCount controls.

    Distribution

    Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR.

    Quantity

    17 units