Class II

Medical Device Recall: BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.

Becton Dickinson & Co. · January 8, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

2,363,168 total units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1016-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.