BEUDAMED
    FDA Enforcement Class III Terminated

    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

    Recall: Z-1390-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1390-2016
    Event ID
    73597
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Biosciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    March 18, 2016
    Classification Date
    April 14, 2016
    Termination Date
    December 2, 2016
    Address
    2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States

    Description

    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

    Reason

    The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.

    Code Info

    Product number 349214, Lot number 5175559, Expiry 5/31/16.

    Distribution

    Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN., and to the countries of : Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.

    Quantity

    205