Recall Z-1075-2025 ยท JTN Susceptibility Test Discs, Antimicrobial
Oxoid Limited
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
| Date | Feb 4, 2025 (initiated Dec 23, 2024) |
| Status | Open, Classified |
| Reason | Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. |
| 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 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., Mar 17, 2006 |