BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0473-2023 · Initiated November 21, 2022

    Recall

    Recall Number
    Z-0473-2023
    Event Number
    91201
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JTY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 21, 2022
    Posted
    December 9, 2022
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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.

    Action

    BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter. to Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached 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 per FDA requirements. Distributors: As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this notification. Email an excel file listing of all customers to [email protected] within 72 hours of receipt of this letter so that BD may initiate customer notification. Actions Taken by BD: BD will issue replacements following receipt of the completed Customer Response Form. Questions: North American Regional Complaint Center .Phone: 1-844-8BD-LIFE (1-844-823-5433) Fri 8:00am and 5:00pm CT or Email: [email protected]

    Distribution

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

    Quantity

    9,600 EA