Print version of this report
TGA Action ID RC-2025-RN-00489-1
Type of Product Medical Device
Product Name/Description BD BACTEC MGIT 960 PZA Kit. An in vitro diagnostic medical device (IVD).

Catalog Number: 245128

Lot Numbers: 3104416, 3128412, 3191569, 3241654, 3269157, 3298311, 3304389, 4009894, 4036330, 4051247, 4150998, 4262039, 4262044, 4284443, 4352110, 5007456

Expiry Dates: 16/07/25 - 29/04/26
ARTG Number 197287
Action Type Recall
Action Level Hospital
Hazard Classification Class II
Reason for the Action In mid-2024, BD initiated an action (RC-2024-RN-00617-1) for the BD BACTEC MGIT 960 PZA Kits. Later that year, following an internal investigation and based on positive expanded performance test results, BD implemented a modification to the raw material to address the problem. BD resumed production while conducting further stability testing.

However, BD has received additional complaints regarding the affected product of intermittent false resistance results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. Concurrently, BD’s additional stability testing suggests that the implemented corrective action may not fully resolve the problem and further investigation is necessary.

There have been no adverse events relating to this problem.
Instructions for Customers/Users Customers are to quarantine, then dispose of affected stock. A BD Associate will be in touch to arrange credit of impacted stock.

There are no recommendations for retesting or reviewing previous patient test results.

UPDATE 25/11/2025:
The Instructions for Use (IFU) have been updated to allow limited use under specific conditions:
· Only inoculum prepared from MGIT tubes 3–5 days post-positivity is supported.
· Inoculum from MGIT tubes 1–2 days post-positivity is not supported.
· Inoculum from solid media is not supported.
· Shelf life reduced from 18 months to 13 months.

This action has been finalised on 10/4/2026.
Action Commencement Date 28/05/2025
Responsible Entity Becton Dickinson Pty Ltd
Contact Information 1800 656 100 - Becton Dickinson