FDA Enforcement
Class II
Ongoing
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
Recall: Z-1018-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-1018-2024
- Event ID
- 93789
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- January 8, 2024
- Classification Date
- February 8, 2024
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212, United States
Description
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
Reason
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.
Code Info
Catalog No. 231696¿ UDI-DI 30382902316962 Lots 2339439 3118297 3163524 3223410 3243084 3282873 2063393 2119624 2119625 2119626 2147720 2213567 2273732
Distribution
Domestic distribution nationwide. International distribution worldwide.
Quantity
2,363,168 total units