BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Reported: July 2, 2025 Initiated: May 20, 2025 #Z-2023-2025
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.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 12,256 eaches
- 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.
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
BD BACTEC" MGIT" 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).. Recalled by Becton Dickinson & Co.. Units affected: 12,256 eaches.
Why was this product recalled? ▼
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2025. Severity: Moderate. Recall number: Z-2023-2025.
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