BD antibiotic susceptibility test discs recalled for possible accuracy failures
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
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 medical device recall with potential for serious diagnostic errors (inappropriate antibiotic selection, delayed diagnosis) that could negatively impact patient treatment. However, no illnesses, injuries, or hospitalizations have been reported, and the identified hazard is described as a possibility rather than confirmed.
Plain-English summary
Becton Dickinson & Co. has recalled BD BBL Sensi Disc Aztreonam - 30 μg susceptibility testing discs (Catalog Numbers 231640 and 231641). These laboratory testing discs are used for antibiotic susceptibility testing to determine bacterial antibiotic resistance. A total of 2,363,168 units are affected, distributed domestically and internationally.
The recall was issued due to the possibility of reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing specifically for H. influenzae. The affected test discs may produce inaccurate or unreliable test results.
These test failures may result in product discard, delayed test results, delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment. The affected products apply to laboratories and healthcare facilities worldwide that have received these discs with the specified lot numbers.
The recalled product
- Product
- BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- antibiotic-selection-error
- diagnostic-delay
Distribution
Distributed nationwide across the United States.
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