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.
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: 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
- Hazard
- false-resistant-result
- diagnostic-inaccuracy
Distribution
Distributed nationwide across the United States.
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