BD BBL clarithromycin susceptibility test discs recalled for accuracy and quality failures
Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.
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 no reported illnesses or injuries. The hazard is theoretical—potential inaccuracy in laboratory test results that could lead to diagnostic and treatment errors—meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs (Catalog No. 231678, affected Lots 1305187, 2119623, 2339435, 3129541) distributed domestically nationwide and internationally worldwide. These in vitro diagnostic devices are used in laboratory testing to determine antibiotic susceptibility for Haemophilus influenzae.
The discs may experience accuracy, reproducibility, and quality-control failures during antibiotic susceptibility testing. These failures could produce inaccurate test results that do not reliably reflect the organism's true susceptibility to clarithromycin.
Inaccurate results may lead to delayed diagnosis, selection of inappropriate antibiotics, or extended antibiotic treatment duration. Laboratories using these discs should immediately cease use of the affected lots and contact the manufacturer to arrange replacement product or obtain guidance on product disposition.
The recalled product
- Product
- BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- reproducibility-failure
- diagnostic-delay
- inappropriate-antibiotic-selection
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. 231678¿ UDI-DI 30382902316788 Lots 1305187 2119623 2339435 3129541
Distribution
Distributed nationwide across the United States.
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