Recall Z-2686-2024 ยท MJA Susceptibility Test Powders, Antimycobacterial
Becton Dickinson & Co.
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
| Date | Aug 16, 2024 (initiated Jul 18, 2024) |
| Status | Open, Classified |
| Reason | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. |
| Root 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 |
| Quantity | 12,383 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Per |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021582 | BACTEC MGIT 960 PZA KIT Becton, Dickinson & CO, Jul 13, 2002 |