DFI Co., Ltd. Recall: One Step K in vitro diagnostic test REF: 81A4
DFI Co., Ltd. Recall: One Step K in vitro diagnostic test REF: 81A4 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling 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 approva
| Recalling 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. |
| Recall initiated | 20260402 |
| Recall number | Z-2087-2026 |
| Category | device |
| Country | Korea (the Republic of) |
$29/mo
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