FDA Medical Device Recalls (openFDA)
DFI Co., Ltd.: One Step 10A in vitro diagnostic test
- Recall number
- Z-2082-2026
- Recalling firm
- DFI Co., Ltd.
- Product
- One Step 10A in vitro diagnostic test
- Status
- Open, Classified
- Initiated
- 2026-04-02
- Posted
- 2026-05-06
- Terminated
- not on file
- 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-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
- Quantity
- 6533 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Lot, serial or model codes
- UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVO
- Firm FEI
- 3005841640
- Firm city
- Jillye-Myeon
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28