FDAClass IIFebruary 12, 2025

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin recall: Labeling Error

Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

Why was Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin recalled?

Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 6142394/UDI: 5032384079629

Product
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Recalling firm
Oxoid Limited
Quantity
1406 units
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
Recall date
February 12, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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