Class IIOngoingZ-2082-2026
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–1 of 1 recalls
The devices were distributed without required FDA premarket clearance or approval.