BEUDAMED
    FDA Enforcement Class II Terminated

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    Recall: Z-1977-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1977-2014
    Event ID
    68490
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD Biosciences, Systems & Reagents
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    June 6, 2014
    Classification Date
    July 1, 2014
    Termination Date
    January 27, 2015
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812, United States

    Description

    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

    Reason

    Laser cooling fans and internal fan of the associated fluidics cart are not operational.

    Code Info

    FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers: V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.

    Quantity

    35 installed devices