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Recall

DFI Co., Ltd.: One Step K in vitro diagnostic test REF: 81A4 Recall

The devices were distributed without required FDA premarket clearance or approval. Product details: One Step K in vitro diagnostic test REF: 81A4

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Agency
FDA
Record ID
Z-2087-2026
Canonical
https://claimwatch-mvp.vercel.app/item/dfi-co-ltd-one-step-k-in-vitro-diagnostic-test-ref-81a4/

What happened?

The devices were distributed without required FDA premarket clearance or approval. Product details: One Step K in vitro diagnostic test REF: 81A4

Who may be affected?

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

What should consumers do?

Affected quantity: 761 units

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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