[pending] BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tu
Pending LLM rewrite. Source: FDA_DEVICE Z-2023-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
The recalled product
- Product
- BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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