Recall Z-0745-2026 ยท NJT Immunohistochemistry Reagents And Kits
GET TESTED INTERNATIONAL AB
MPOX Test
| Date | Dec 1, 2025 (initiated Nov 3, 2025) |
| Status | Open, Classified |
| Reason | Distribution without premarket approval/clearance. |
| Root cause | No Marketing Application |
| Action | On November 3, 2025, MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: If you still have an unused test, it should not be used. You should render the kit unusable and discard the defaced components in accordance with ordinary household disposal practices and applicable local regulations. If your kit has already been used: You do not need to return used components. Please do not base medical decisions solely on that prior result and do not use any remaining units. If you have questions about your results or your health, consult your healthcare provider, who may recommen |
| Quantity | 4 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.