Becton Dickinson & Co.: BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution nationwide. International distribution worldwide. Quantity: 2,363,168 total units Lot/code info: Catalog No. 231705 UDI-DI 00382902317050 Lots 1334510 2004644 2091272 2277179 3030830 3094117 3248344; Catalog No. 231706¿ UDI-DI 30382902317068 Lots 2277179 3030830 3094117 3184118 3248344 1334510 2004644 2091272 2213599

UPC codes

00382902317050, 30382902317068

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.