Device product
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Z-1075-2025
Product summary
- Firm
- Oxoid Limited
- Event
- Event 96113
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1406 units
- Official record key
device-enforcement:Z-1075-2025
Official wording
Reason: Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Code information: Lot # 6142394/UDI: 5032384079629
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
Mislabeling