BEUDAMED
    FDA Enforcement Class II Ongoing

    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    Recall: Z-0473-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0473-2023
    Event ID
    91201
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    November 21, 2022
    Classification Date
    December 9, 2022
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

    Reason

    Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

    Code Info

    UDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

    Quantity

    9,600 EA