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Medical Device

One Step K in vitro diagnostic test REF: 81A4

Recall date: 2026-05-13 · Source: FDA_DEVICE
Brand / Firm
DFI Co., Ltd.
Product
One Step K in vitro diagnostic test REF: 81A4
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
Units affected
761 units
Description
One Step K in vitro diagnostic test REF: 81A4
View official recall notice →