BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.
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: FDA Class II device with potential for serious diagnostic harm including delayed diagnosis and inappropriate antibiotic selection, but no reported illnesses or injuries. Qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling specific lots of BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim discs, which are used for semi-quantitative in vitro antibiotic susceptibility testing. The company identified a possibility of reproducibility, accuracy, and quality control failures that specifically affect H. influenzae testing.
Approximately 2,363,168 units have been distributed domestically and internationally. Affected products include Catalog Nos. 231536 and 231539, with specific lot numbers detailed in the recall notice.
The potential failures may result in product discard or delayed test results, leading to adverse diagnostic outcomes. These may include delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment.
The recalled product
- Product
- BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- reproducibility-failure
- quality-control-failure
- delayed-diagnosis
- inappropriate-antibiotic-selection
Distribution
Distributed nationwide across the United States.
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