| | Class 2 Device Recall Oxoid" Levofloxacin Antimicrobial Susceptibility discs |  |
| Date Initiated by Firm | December 23, 2024 |
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| Date Posted | February 04, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1075-2025 |
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| Recall Event ID |
96113 |
| 510(K)Number | K060286 |
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| Product Classification |
Susceptibility test discs, antimicrobial - Product Code JTN
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| Product | Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 |
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| Code Information |
Lot # 6142394/UDI: 5032384079629 |
Recalling Firm/
Manufacturer |
Oxoid Limited
Wade Road
Basingstoke United Kingdom
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| For Additional Information Contact | Erica Knox
800-255-6730 |
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Manufacturer Reason
for Recall | Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 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 |
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| Quantity in Commerce | 1406 units |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JTN
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