FDA-Device2024-02-14Class II
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
Becton Dickinson & Co.
Hazard
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Sold states
Domestic distribution nationwide. International distribution worldwide.
Affected count
2,363,168 total units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1028-2024Don't want to check this manually?
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