Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Myc…

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

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

***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.

• FDA enforcement recordOfficial FDA database entry for Z-2023-2025
• FDA 510(k) clearance · K021582The device's official FDA premarket clearance record
• FDA device classification · MJAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Becton Dickinson & Co.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.