BEUDAMED
    FDA Recall 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 · Initiated June 21, 2018

    Recall

    Recall Number
    Z-2869-2018
    Event Number
    80573
    Firm
    Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    JTY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 21, 2018
    Terminated
    July 9, 2019
    Address
    Sparks, MD, 21152-9212

    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.

    Action

    The firm, BD Diagnostic System, sent an "URGENT MEDICAL DEVICE PRODUCT RECALL" letter dated June 21, 2018, to its customers via UPS, to the attention of Microbiology Manager/Supervisor. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: I. Complete the Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Discard any remaining inventory of lot 8110781 . BD will process replacement of any discarded inventory upon receipt of the Customer Response Form. 3. Share this Recall Letter with all users of the product within your facility to ensure awareness. BD has identified the root cause of this situation and has initiated corrective actions to prevent recurrence in the future. If you require further assistance, please contact: 800-638-8663 Customer/Technical Support Monday- Friday between 7:00am and 7:00pm (EST) in the United States.

    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