BEUDAMED
    FDA Enforcement Class II Terminated

    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    Recall: Z-2048-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2048-2020
    Event ID
    85508
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    April 14, 2020
    Classification Date
    May 19, 2020
    Termination Date
    February 10, 2022
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    Reason

    May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain

    Code Info

    Lot Number/ Exp Date: 0007261 06/30/21; 0007255 05/31/21; 0028309 03/30/21. Expanded 5/12/20-Lot Numbers/Exp. Date: 0041114 07/31/21; 0014322 06/30/21

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.

    Quantity

    1469 kits