Recall Z-1947-2025 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Remel, Inc
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
| Date | Jun 11, 2025 (initiated May 1, 2025) |
| Status | Open, Classified |
| Reason | Product may have an off color affecting perfomance |
| Root cause | Under Investigation by firm |
| Action | Thermo Fisher Scientific issued an Urgent: Medical Device Recall notice to its consignees on 05/01/2025 via USPS First Class Mail. The notice explained the issue with the device, potential risk to health, and requested the following: "Accordingly, in keeping with our Quality Policy, we request that a review of test results should be evaluated by an appropriate technical expert. Please keep this notification on file. Also, destroy any remaining inventory of the lot listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed |
| Quantity | 70 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111429 | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... Trek Diagnostic Systems, Ltd., Aug 18, 2011 |