Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Summary
The FDA issued a Class II for Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 by Oxoid Limited. Reason: Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs..
Details
Source
Device Recall
External ID
Z-1075-2025
Action Date
2025-02-12
Status
Ongoing
Category
device
Product Description
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Lot/Code Info: Lot # 6142394/UDI: 5032384079629
Quantity Affected: 1406 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-23
Company
Basingstoke
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Oxoid Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oxoid Limited have FDA actions?
This is the only FDA action we have on record for Oxoid Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1075-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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