BEUDAMED
    FDA Recall Terminated

    BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.

    Recall: Z-0316-2011 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-0316-2011
    Event Number
    55748
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 19, 2010
    Posted
    November 3, 2010
    Terminated
    May 18, 2011
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.

    Reason

    Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. The piece of the lid clogging the Probe can be in the processed sample tube. It has the

    Action

    BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.

    Distribution

    Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.

    Quantity

    349 units