BEUDAMED
    FDA Enforcement Class II Terminated

    BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.

    Recall: Z-2869-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2869-2018
    Event ID
    80573
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 29, 2018
    Initiation Date
    June 21, 2018
    Classification Date
    August 17, 2018
    Termination Date
    July 9, 2019
    Address
    7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States

    Description

    BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.

    Reason

    A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment.

    Code Info

    8110781

    Distribution

    US Distribution in states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, ID, IN, KS, KY, MA, MI, MS, MT, NC, JH, NY, OK, OR, PA, SC, TN, TX, WA, and WI.

    Quantity

    10,360 plates