BEUDAMED
    FDA Enforcement Class II Terminated

    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

    Recall: Z-2453-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2453-2015
    Event ID
    71826
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 17, 2015
    Classification Date
    August 24, 2015
    Termination Date
    March 11, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

    Reason

    Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.

    Code Info

    Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015

    Distribution

    US Distribution and Internationally to Taiwan.

    Quantity

    362 units