BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Urine Collection Cups, Cat. No. 364941

    Recall: Z-0491-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0491-2019
    Event ID
    81148
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 28, 2018
    Initiation Date
    August 30, 2018
    Classification Date
    November 21, 2018
    Termination Date
    October 21, 2020
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Urine Collection Cups, Cat. No. 364941

    Reason

    BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.

    Code Info

    All lots within expiry

    Distribution

    Illinois

    Quantity

    Total: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)