Recall Z-2088-2026
DFI Co., Ltd. · initiated April 2, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
One Step P in vitro diagnostic test REF: 8194
Codes / lots: UDI:08806141302025/ Lot: 241023, 250527, 250905
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
FDA-determined cause: No Marketing Application
Action taken
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-distributor Notification: Immediately notify all sub-distributors or end customers receiving Products. 4.2 End Customer required Actions 1) Stop using the product immediately. 2) Do not give or sell the product to anyone else. 3) Follow the instructions below regarding destruction or disposal. 4) Submit your refund / confirmation request as instructed. < Destruction / Disposal Instructions > To prevent accidental use, please cut the unused test strip(s) in half. After cutting the strips in half, please dispose of the destroyed components in accordance with your local municipal waste regulations
Details
- Recall number
- Z-2088-2026
- Initiated
- April 2, 2026
- Posted by FDA
- May 6, 2026
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Quantity
- 1064 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Recalling firm
- DFI Co., Ltd., Jillye-Myeon
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2082-2026 Class II | One Step 10A in vitro diagnostic testThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2083-2026 Class II | One Step UTI in vitro diagnostic test REF: 3374The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2084-2026 Class II | One Step pH in vitro diagnostic test REF: 31I4PThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2085-2026 Class II | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2086-2026 Class II | Uric Acid in vitro diagnostic test REF: 31H0PThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2087-2026 Class II | One Step K in vitro diagnostic test REF: 81A4The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |