Z-2082-2026Class II

One Step 10A in vitro diagnostic test

Name: Z-2082-2026 One Step 10A in vitro diagnostic test
Creator: DFI Co., Ltd.
Published: 2026-04-02
License: https://open.fda.gov/license/

DFI Co., Ltd. / initiated 2026-04-02 / Open, Classified

FDA source

DFI Co., Ltd. began a recall of One Step 10A in vitro diagnostic test on 2026-04-02. FDA classified it as Class II and gives the reason as "The devices were distributed without required FDA premarket clearance or approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2082-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-05-06
Recalling firm: DFI Co., Ltd.
Product: One Step 10A in vitro diagnostic test
Product code: MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Reason for recall: The devices were distributed without required FDA premarket clearance or approval.
FDA 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 in commerce: 6533 units
Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Product codes and lots: UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2082-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2082-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2083-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2084-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2085-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2086-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2087-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06
Z-2088-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code MVO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)