Z-2023-2025 Class II Ongoing
FDA device recall Z-2023-2025 was initiated by Becton Dickinson & Co. on May 20, 2025 and is designated Class II. Reason for recall: BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates. The recall status is ongoing. Affected quantity: 12,256 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,256 eaches
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.
Distribution Pattern
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.
Code Information
Catalog No. 245128; UDI-DI: (01) 0038290245128; Lot No. 4150998, 4177908, 4178500, 4262031, 4262036, 4262037, 4262039, 4262040, 4262044, 4284438, 4284441, 4284443, 4284445, 4284449, 4304789, 4304796, 4347228, 4347230, 4352110, 4362418, 5007456, 5020153, 5050670, 5050671, 5050672, 5050675, 5050678.