One Step UTI in vitro diagnostic test recallZ-2083-2026 · DFI Co., Ltd. · initiated Apr 2, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DFI Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The devices were distributed without required FDA premarket clearance or approval.
FDA root cause category: No Marketing Application
What the company is doing
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
Recall details
- Recall number
- Z-2083-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 2, 2026
- Posted by the FDA
- May 6, 2026
- Recalling firm
- DFI Co., Ltd.
- Quantity
- 2423 units
- Product code
- LJX
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Product description
One Step UTI in vitro diagnostic test REF: 3374
Code information (models, lots, serial numbers)
UDI: 08806141303480/ Lot: 241023, 250625, 250905
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- One+Step UTI 3374Dfi CO.,Ltd · Test, Urine Leukocyte1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98739).
- Z-2082-2026 · Open, ClassifiedOne Step 10A in vitro diagnostic test
- Z-2084-2026 · Open, ClassifiedOne Step pH in vitro diagnostic test REF: 31I4P
- Z-2085-2026 · Open, ClassifiedQUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- Z-2086-2026 · Open, ClassifiedUric Acid in vitro diagnostic test REF: 31H0P
- Z-2087-2026 · Open, ClassifiedOne Step K in vitro diagnostic test REF: 81A4
- Z-2088-2026 · Open, ClassifiedOne Step P in vitro diagnostic test REF: 8194
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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