Recall Z-1075-2025— Oxoid Limited

Name: FDA recall Z-1075-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

Class II · Ongoing

Class II FDA medical device recall by Oxoid Limited, initiated 2024-12-23. It names one FDA 510(k) clearance: K060286. Product: 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..

Recalling firm: Oxoid Limited
Classification: Class II
Status: Ongoing
Initiated: 2024-12-23
Firm location: Basingstoke, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·cleared 2006-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.