BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure recall
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Why was BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure recalled?
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 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.
- Recall date
- July 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)