Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing
The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 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 3/5 (High).
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: This Class II diagnostic test recall involves potential false results that could affect tuberculosis treatment decisions. Although no illnesses or injuries are reported, the device presents a risk of harm through diagnostic inaccuracy.
Plain-English summary
The BD BACTEC MGIT 960 PZA Kit is a diagnostic test used to determine whether Mycobacterium tuberculosis isolates are resistant to pyrazinamide (PZA), an important anti-TB medication. Becton Dickinson & Co. is recalling 12,383 units of this kit.
The kit may intermittently produce falsely resistant results, meaning it could incorrectly indicate that a TB isolate is resistant to pyrazinamide when it may actually be susceptible. This could lead clinicians to avoid a potentially effective medication.
The recalled products have been distributed worldwide, including across the United States and to multiple international locations. Affected lot numbers include 3104416, 3156654, 3191569, 3233971, 3241654, 3248314, 3269157, 3298311, 3298317, 3304389, 3324422, 3338965, 4002353, 4009894, 4036330, and 4051247.
Healthcare providers and laboratories using this kit should stop use of affected lots and contact Becton Dickinson & Co. for instructions on replacement. Consultation with public health authorities is recommended for patients whose TB treatment decisions may have been based on results from recalled kits.
The recalled product
- Product
- BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 12,383
Distribution
Distributed nationwide across the United States.
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 resistant result
See all →- HighBD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results
FDA (Devices) · 2024-10-16
Similar recalls
- SevereBD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall
FDA (Devices) · 2025-07-02
- HighBD Phoenix PMIC-109 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
- HighBD Phoenix PMIC/ID-109 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
- SevereBD Phoenix PMIC-107 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06