BEUDAMED
    FDA Enforcement Class III Terminated

    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.

    Recall: Z-1876-2017 · Reported May 3, 2017

    Enforcement

    Recall Number
    Z-1876-2017
    Event ID
    76930
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 3, 2017
    Initiation Date
    March 27, 2015
    Classification Date
    April 25, 2017
    Termination Date
    April 26, 2017
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.

    Reason

    BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.

    Code Info

    Part/Cat No. 221302 Lot / Serial No. 4365741

    Distribution

    US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA

    Quantity

    1600 plates