BEUDAMED
    FDA Recall Terminated

    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

    Recall: Z-1370-2015 · Initiated March 6, 2015

    Recall

    Recall Number
    Z-1370-2015
    Event Number
    70678
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 6, 2015
    Posted
    June 26, 2015
    Terminated
    April 4, 2016
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

    Reason

    The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.

    Action

    BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.

    Distribution

    Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim

    Quantity

    72 devices