Z-1075-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- December 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1406 units
Product Description
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Reason for Recall
Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
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
Code Information
Lot # 6142394/UDI: 5032384079629