BD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall. False resistance results in tuberculosis drug-susceptibility testing could lead to inappropriate treatment decisions, failure to identify drug resistance, and consequently serious patient harm including treatment failure and disease progression. This meets the Severe criterion for Class II recalls with significant risk of harm.
Plain-English summary
Becton Dickinson & Co. is recalling the BD BACTEC MGIT 960 PZA Kit, an in vitro diagnostic device used for susceptibility testing of Mycobacterium tuberculosis to the drug pyrazinamide (PZA). The company has received complaints of intermittent false resistance results during susceptibility testing with this kit.
The affected product was distributed worldwide, including throughout the United States and internationally to Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Hong Kong, Haiti, Indonesia, India, Japan, Cambodia, South Korea, Macau, Mexico, Malaysia, Nepal, New Zealand, Peru, Philippines, Pakistan, Singapore, El Salvador, Thailand, and Taiwan. The recalled lot numbers are 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, and 5050678. The catalog number is 245128.
Healthcare providers and laboratories using this kit should review their testing results for PZA susceptibility and consider retesting if warranted. Customers should contact Becton Dickinson for additional information or corrective actions.
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.
- Affected units
- 12,256
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
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