Gimhae, Korea (the Republic of)
DFI Co., Ltd. recalls
1 recall recorded since 2018, most recently on 2 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 April 2026
- Reason
- The devices were distributed without required FDA premarket clearance or approval.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2087-2026, Z-2086-2026, Z-2085-2026, Z-2088-2026, Z-2084-2026, Z-2082-2026, Z-2083-2026
- One Step K in vitro diagnostic test REF: 81A4
- Uric Acid in vitro diagnostic test REF: 31H0P
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- One Step P in vitro diagnostic test REF: 8194
- One Step pH in vitro diagnostic test REF: 31I4P
- One Step 10A in vitro diagnostic test
- One Step UTI in vitro diagnostic test REF: 3374
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.