One Step 10A in vitro diagnostic test — Class II medical device recall Z-2082-2026
Ongoing recall by DFI Co., Ltd., reported 2026-05-13, distributed nationwide. The devices were distributed without required FDA premarket clearance or approval.
| Recall number | Z-2082-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DFI Co., Ltd., Gimhae, Korea (the Republic of) |
| Recall initiated | 2026-04-02 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 6,533 units |
| UPC / GTIN / UDI-DI | 08806141303497 |
| Lot numbers | 241023, 250305, 250415, 250527, 250625, 250905 |
Product
One Step 10A in vitro diagnostic test
Reason for recall
The devices were distributed without required FDA premarket clearance or approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2082-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.