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Becton Dickinson & Co. recalls BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t
Recalled February 14, 2024 · FDA recall Z-1039-2024 · Becton Dickinson &
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. · FDA Class II
Units
2,363,168 total units
Sold at
Domestic distribution nationwide. International distribution worldwide.
Description
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.
Product
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →