Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5… recallZ-1075-2025 · Oxoid Limited · initiated Dec 23, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Oxoid Limited or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On December 23, 2024 Oxoid a subsidiary of Thermo Fischer Scientific issued a Medical Device Recall notification. via mail to affected consignees. Thermo Fischer Scientific asked consignees to take the following action: 1. Destroy any remaining inventory of the lot 2. Complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to [email protected] in order for your replacement/credit to be processed. 3. Please keep this notification on file. 4. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 5. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]. 6. Report any adverse health consequences experienced with the use of this product to Remel Inc. Events may also be reported to the FDA s MedWatch Adverse Event Reporting program via: Web: www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville MD 20852-9787

Recall details

Recall number: Z-1075-2025
Status: Open, Classified
Initiated by the company: Dec 23, 2024
Posted by the FDA: Feb 4, 2025
Recalling firm: Oxoid Limited
Quantity: 1406 units
Product code: JTN
FDA submissions: K060286
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

Product description

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

Code information (models, lots, serial numbers)

Lot # 6142394/UDI: 5032384079629

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA CT1587B
Oxoid Limited · Susceptibility Test Discs, Antimicrobial
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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