BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to 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: This is an FDA Class II recall of a diagnostic test product with potential for incorrect test results. No illnesses or injuries have been reported. The recall addresses theoretical risk of diagnostic delay and inappropriate antibiotic selection, which qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Ceftaroline - 30 ug antibiotic susceptibility test discs. The recalled product is used in laboratory settings for semi-quantitative in vitro susceptibility testing. A total of 2,363,168 units have been distributed both domestically and internationally.
The discs may experience reproducibility, accuracy, and quality control failures when used in antibiotic susceptibility testing for Haemophilus influenzae. These failures could result in inaccurate test outcomes, which may lead to diagnostic delays, inappropriate antibiotic selection, or extended duration of antibiotic exposure.
Clinical laboratories and healthcare facilities that use these test discs are affected. The recalled lots include Catalog Number 232231, Lots 3116030 and 3212690 (UDI-DI 30382902322314).
The recalled product
- Product
- BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- test-inaccuracy
- diagnostic-delay
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 (1)
- Catalog No. 232231¿ UDI-DI 30382902322314 Lots 3116030 3212690
Distribution
Distributed nationwide across the United States.
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