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Medical Device

One Step 10A in vitro diagnostic test

Recall date: 2026-05-13 · Source: FDA_DEVICE
Brand / Firm
DFI Co., Ltd.
Product
One Step 10A in vitro diagnostic test
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
Units affected
6533 units
Description
One Step 10A in vitro diagnostic test
View official recall notice →