Becton Dickinson TB susceptibility test kit recalled for intermittent false results
Becton Dickinson is recalling the BD BACTEC MGIT 960 PZA Kit, a tuberculosis drug-resistance test, due to intermittent false resistance results. Approximately 12,256 units were 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 is an FDA Class II recall with no reported illnesses or injuries documented in the source text. The hazard is intermittent false test results that could theoretically affect TB treatment decisions. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3.
Plain-English summary
The BD BACTEC MGIT 960 PZA Kit is a laboratory diagnostic device used to test whether Mycobacterium tuberculosis is susceptible or resistant to the antibiotic pyrazinamide (PZA).
Becton Dickinson has received complaints of intermittent false resistance results when using this kit to test TB bacteria isolates. Approximately 12,256 units have been distributed worldwide, including throughout the United States and to 30+ countries internationally.
The affected product is identified by catalog number 245128. The FDA has classified this as a Class II recall. Additional information is available from Becton Dickinson and the FDA.
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.
- Hazard
- diagnostic-inaccuracy
- false-positive-resistance
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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