BD antibiotic susceptibility testing discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or 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 recall with no reported illnesses or injuries. The potential for testing accuracy failures affecting antibiotic susceptibility results could lead to delayed diagnosis and inappropriate antibiotic selection, representing significant patient care risk. Per rubric criteria for risk-of-harm products without reported injury, score is 3 (High).
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs (catalog numbers 230705, 231264, and 231263). The recall affects approximately 2,363,168 units distributed domestically and worldwide. The discs may have accuracy, reproducibility, or quality control failures that could impact test results.
These failures may cause delayed or inaccurate results in antibiotic susceptibility testing for H. influenzae. This could result in delayed diagnosis, selection of inappropriate antibiotics, or extended unnecessary antibiotic exposure. No illnesses or injuries have been reported.
Healthcare facilities and laboratories using these discs should immediately discontinue use of affected lots. Contact Becton Dickinson for replacement or instructions. Specific lot numbers are available on the FDA recall notification.
The recalled product
- Product
- BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- diagnostic-delay
- antibiotic-selection
Distribution
Distributed nationwide across the United States.
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