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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
Same hazard · false test result
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighEstrone RIA Diagnostic Kit Recall by Immunotech A.S.
FDA (Devices) · 2026-02-25
- HighMedline Stat-Site B-HB Diluent Recalled for Potential Test Inaccuracy
FDA (Devices) · 2021-04-21
- SevereBiomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect
FDA (Devices) · 2021-03-31
- HighBeckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure
FDA (Devices) · 2020-12-30
Similar recalls
- HighDiagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing
FDA (Devices) · 2024-08-28
- HighBD Phoenix PMIC-109 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06
- HighBD Phoenix PMIC/ID-109 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06
- SevereBD Phoenix PMIC-107 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06
- HighBD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06
- HighBD Phoenix PMIC/ID-108 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06