Recall Z-2087-2026— DFI Co., Ltd.

Name: FDA recall Z-2087-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-02

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 K in vitro diagnostic test REF: 81A4. 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 K in vitro diagnostic test REF: 81A4

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.