Becton Dickinson & Co.: BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿

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. 231678¿ UDI-DI 30382902316788 Lots 1305187 2119623 2339435 3129541

UPC codes

30382902316788

Source

Official record: FDA (Device enforcement) ↗

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