Z-1075-2025Class II

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

Name: Z-1075-2025 Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Creator: Oxoid Limited
Published: 2024-12-23
License: https://open.fda.gov/license/

Oxoid, Ltd. / initiated 2024-12-23 / Open, Classified / root cause: labeling and UDI

FDA source

Oxoid Limited began a recall of Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 on 2024-12-23. FDA classified it as Class II and gives the reason as "Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1075-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-23
Posted: 2025-02-04
Recalling firm: Oxoid, Ltd.
Product: Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 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
Product codes and lots: Lot # 6142394/UDI: 5032384079629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

Product code JTN

K060286Class IITigecycline Antimicrobial Susceptibility Test DiscOxoid , Ltd. / cleared 2006-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)