Summary
The FDA issued a Class II for One Step 10A in vitro diagnostic test by DFI Co., Ltd.. Reason: The devices were distributed without required FDA premarket clearance or approval..
Details
Source
Device Recall
External ID
Z-2082-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
One Step 10A in vitro diagnostic test
Lot/Code Info: UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
Quantity Affected: 6533 units
Reason for Recall
The devices were distributed without required FDA premarket clearance or approval.
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-02
Company
Gimhae
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DFI Co., Ltd. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DFI Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DFI Co., Ltd. have FDA actions?
DFI Co., Ltd. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2082-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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