Becton Dickinson & Co.: BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

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. 231606 UDI-DI 00382902316060 Lots 2004580 2025164 2090467 2146516 2180432 2301360 3003886; Catalog No. 231607 UDI-DI 30382902316078 Lots 2301360 3062270 3158078 3261093 2004580 2025164 2090467 2146516 2180432 3003886; Catalog No. 291308¿ UDI-DI N/A Lots 2301468 3003046 3093596 3116037 3248537 3248540

UPC codes

00382902316060, 30382902316078

Source

Official record: FDA (Device enforcement) ↗

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