FDA recall Z-1011-2024

Becton Dickinson & Co. · Class II · device

Product

Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing

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.

Key facts

Status
Ongoing
Initiation date
2024-01-08
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2024