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

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

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