BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1370-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1370-2015
    Event ID
    70678
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    March 6, 2015
    Classification Date
    April 2, 2015
    Termination Date
    April 4, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    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.

    Code Info

    Serial Nos. E34297300656, E34297300657, E34297300659, E34297300660, E34297300661, E34297300666, E34297300667, E34297300668, E34297300669, E34297300670, E34297300671, E34297300673, E34297300675, E34297300676, E34297300677, E34297300678 E34297502563, E34297502564, E34297502565, E34297502566, E34297502567, E34297502568, E34297502569, E34297502570, E34297502571, E34297502572, E34297502573, E34297502574, E34297502575, E34297502576, E34297502577, E34297502578, E34297502579, E34297502580, E34297502581, E34297502583, E34297502584, E34297502585, E34297502586, E34297502587, E34297502588, E34297502589, E34297502590, E34297502591, E34297502592, E34297502593, E34297502594, E34297502595, E34297502596, E34297502597, E34297502599, E34297502600, E34297502601, E34297502602, E34297502603, E34297502604, E34297502605, E34297502606, E34297502607, E34297502608, E34297502612, E34297502613, E34297502619, E34297502620, E34297502621, E34297502629, E34297600499, E34297600501, E34297600502, E34297600503, E34297600507, E34297600508.

    Distribution

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

    Quantity

    72 devices