Recall Z-2023-2025— Becton Dickinson & Co.

Name: FDA recall Z-2023-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-20

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2025-05-20. It names one FDA 510(k) clearance: K021582. Product: 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-20
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K021582 — BACTEC MGIT 960 PZA KITBecton, Dickinson & CO·cleared 2002-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.