FDA Enforcement
Class II
Ongoing
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Recall: Z-1075-2025
·
Reported February 12, 2025
Enforcement
- Recall Number
- Z-1075-2025
- Event ID
- 96113
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oxoid Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- February 12, 2025
- Initiation Date
- December 23, 2024
- Classification Date
- February 4, 2025
- Address
- Wade Road, Basingstoke, N/A, United Kingdom
Description
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Reason
Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Code Info
Lot # 6142394/UDI: 5032384079629
Distribution
US: VA, CA, NE, MA, FL, CA, MA, NH, WA OUS: Austria, Australia, Brazil, Canada, China, Costa Rica, Germany, Spain, France, United Kingdom, Ghana, Hong Kong, South Korea, Netherlands, Peru, Philippines, Poland, Indonesia
Quantity
1406 units