BEUDAMED
    FDA Recall Open, Classified

    BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).

    Recall: Z-2023-2025 · Initiated May 20, 2025

    Recall

    Recall Number
    Z-2023-2025
    Event Number
    96910
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    MJA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 20, 2025
    Posted
    June 25, 2025
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).

    Reason

    BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

    Action

    ***UPDATE 11/13/2025*** BD Issued an URGENT: Medical Device Correction letters were sent to customers. BD is pleased to announce that we have resumed production of a modified version of the BD BACTEC" MGIT" 960 PZA Kit which includes modified inoculation methods and reduced shelf-life. BD has conducted a thorough review of the performance from all supported inoculum sources using the synthetic raw material and the following change has been implemented for the BD BACTEC" MGIT" 960 PZA Kit. 1. Only inoculum prepared from MGIT tubes 3-5 days post-positivity can be currently supported. 2. Inoculum prepared from MGIT tubes 1-2 days past instrument positivity are currently not supported. 3. Inoculum prepared from solid media are currently not supported. Additionally, the shelf life of the product has been adjusted from 18 months to 13 months to reflect the latest internal supporting data. Clinical users should refer to the updated Instructions for Use (IFU) available at https://www.bd.qarad.eifu.online/hcp. Additional languages will be added as translations are completed. An URGENT: Medical Device Correction notice dated 5/20/25 was sent to consignees via mail. The notification instructs consignees to inspect their inventory for recalled units and destroy them per their institution's process of destruction. The recall notification is to be shared at consignee locations with those who utilize the device and to customers who received distributed product. Consignees are to return a completed Customer Response Form to BD. Consignees with any questions are to email [email protected]. Consignees are to report any complaints by phone to 1-844-823-5433 or by email at [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE, BN, BR, CA, CN, CR, DO, GT, HK, HT, ID, IN, JP, KH, KR, MO, MX, MY, NP, NZ, PE, PH, PK, SG, SV, TH, TW, VN.

    Quantity

    12,256 eaches