One Step 10A in vitro diagnostic test
One Step 10A in vitro diagnostic test recalled for lack of FDA clearance.
Stop using the One Step 10A in vitro diagnostic test and contact DFI Co., Ltd. for instructions on returning the product and obtaining a refund.
Why it was recalled
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because the devices were distributed without required FDA premarket clearance or approval, meaning their safety and effectiveness have not been established.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| One Step K in vitro diagnostic test REF: 81A4 | 241023, 250625, 250905 | Z-2087-2026 | 08806141302650 |
| Uric Acid in vitro diagnostic test REF: 31H0P | 241023, 250415, 250509, 250617, 250905 | Z-2086-2026 | 08806141303077 |
| QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | BS032501, BS042502, BS062501, BS062502, BS082501 | Z-2085-2026 | 08806141303060 |
| One Step pH in vitro diagnostic test REF: 31I4P | 250305, 250415, 250509, 250625, 250905 | Z-2084-2026 | 08806141303060 |
| One Step P in vitro diagnostic test REF: 8194 | 241023, 250527, 250905 | Z-2088-2026 | 08806141302025 |
| One Step 10A in vitro diagnostic test | 241023, 250305, 250415, 250527, 250625, 250905 | Z-2082-2026 | 08806141303497 |
| One Step UTI in vitro diagnostic test REF: 3374 | 241023, 250625, 250905 | Z-2083-2026 | 08806141303480 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification