Class 2 Device Recall BD BACTEC" MGIT" 960 PZA Kit

• Date Initiated by Firm: May 20, 2025
• Date Posted: June 25, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2023-2025
• Recall Event ID: 96910
• 510(K)Number: K021582
• Product Classification: Susceptibility test powders, antimycobacterial - Product Code MJA
• Product: BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
• Code Information: Catalog No. 245128; UDI-DI: (01) 0038290245128; Lot No. 4150998, 4177908, 4178500, 4262031, 4262036, 4262037, 4262039, 4262040, 4262044, 4284438, 4284441, 4284443, 4284445, 4284449, 4304789, 4304796, 4347228, 4347230, 4352110, 4362418, 5007456, 5020153, 5050670, 5050671, 5050672, 5050675, 5050678.
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
• FDA Determined Cause: Under Investigation by firm
• 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 BDRC12@bd.com. Consignees are to report any complaints by phone to 1-844-823-5433 or by email at productcomplaints@bd.com.
• Quantity in Commerce: 12,256 eaches
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MJA