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

FDA device recall Z-1075-2025 · posted 2025-02-04 · Open, Classified

Recall details

Recalling firm

Oxoid Limited

Reason for recall

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

Action taken

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 MBD.vigilance@thermofisher.com 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 microbiology.ts.us@thermofisher.com. 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JTN

Quantity affected

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

Date initiated

2024-12-23

Date posted

2025-02-04

Location

Basingstoke, United Kingdom

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