Class II

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

Becton Dickinson & Co. · May 20, 2025

Reason for Recall

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

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.

States Affected

NATIONWIDE

Quantity Affected

12,256 eaches

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2023-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.