One Step UTI in vitro diagnostic test REF: 3374

FDA device recall Z-2083-2026 · posted 2026-05-06 · Open, Classified

Recall details

Recalling firm

DFI Co., Ltd.

Reason for recall

The devices were distributed without required FDA premarket clearance or approval.

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

Root cause

No Marketing Application

Status

Open, Classified

Product code

LJX

Quantity affected

2423 units

Distribution

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

Date initiated

2026-04-02

Date posted

2026-05-06

Location

Jillye-Myeon