Recall Z-2082-2026— DFI Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by DFI Co., Ltd., initiated 2026-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: One Step 10A in vitro diagnostic test. Reason: The devices were distributed without required FDA premarket clearance or approval..
- Recalling firm
- DFI Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-02
- Firm location
- Gimhae, Korea (the Republic of)
Product description
One Step 10A in vitro diagnostic test
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.