FDA recall Z-1075-2025

Product

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

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

Key facts

Status

Ongoing

Initiation date

2024-12-23

Report date

2025-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Basingstoke, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2025