Recall Z-2086-2026 ยท KNK Acid, Uric, Uricase (Colorimetric)
DFI Co., Ltd.
Uric Acid in vitro diagnostic test REF: 31H0P
| Date | May 6, 2026 (initiated Apr 2, 2026) |
| Status | Open, Classified |
| Reason | The devices were distributed without required FDA premarket clearance or approval. |
| Root cause | No Marketing Application |
| Action | On April 2, 2026 Dream Future Innovation (DFI Co., Ltd.) issued a Urgent Medical Device Recall Notification to affected consignees via E. Mail. DFI ask consignees to take the following actions: 4.1 Distribution required Actions 1) Immediate Discontinuation: Immediately stop the use and distribution of the Products. 2) Inventory Quarantine: Quarantine all remaining inventory in a safe place and attach a NOT FOR SALE label. 3) Reply to Acknowledgement: Please fill out the attached Recall Acknowledgement Report and return it within 10 business days of receiving this notice 4) Sub-distribu |
| Quantity | 59815 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.