BEUDAMED
    FDA Recall Terminated

    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

    Recall: Z-0494-2019 · Initiated August 30, 2018

    Recall

    Recall Number
    Z-0494-2019
    Event Number
    81148
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JTW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 30, 2018
    Terminated
    October 21, 2020
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

    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.

    Action

    On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers. Sysmex was instructed to take the following actions: - Notify Sysmex customers of the potential for elevation of RBC counts - Complete the customer Resopnse form and email it to BD at [email protected] to confirm receipt of the Safety Alert. Product will continue to ship so as to not impact critical patient care. BD recommends following Good Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.

    Distribution

    Illinois

    Quantity

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