medical Class II Updated 2024-02-14

Becton Dickinson & Co. recalls BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantita

Recalled Product

BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog No. 231634 UDI-DI 00382902316343 Lots 1033870 1244758 2026381 2056573 2277488; Catalog No. 231635¿ UDI-DI 30382902316351 Lots 3062288 3158099 3254299 0344489 1033870 1088039 1116107 1148606 1180379 1211608 1244758 1335697 2026381 2028922 2056573 2180451 2277488 2277490
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