Class II — DFI Co., Ltd.
| Recalling firm | DFI CO., LTD. |
|---|---|
| Registered facility | DFI CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The devices were distributed without required FDA premarket clearance or approval. |
| Product | One Step P in vitro diagnostic test REF: 8194 |
| Quantity | 1064 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. |
| Initiated | 2026-04-02 |
| Classified | 2026-05-06 |
| Recall number | Z-2088-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DFI Co., Ltd. (Z-2088-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98739/
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