DFI Co., Ltd.
FDA Regulatory Profile
DFI Co., Ltd. has 7 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2082-2026 · Class II · Apr 2, 2026
- Latest inspection
- Jan 9, 2025 · OAI
- Latest 510(k)
- May 23, 2018
Reviewing DFI Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check DFI Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 7 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2082-2026 | Class II | One Step 10A in vitro diagnostic test | Apr 2, 2026 |
| Z-2083-2026 | Class II | One Step UTI in vitro diagnostic test REF: 3374 | Apr 2, 2026 |
| Z-2084-2026 | Class II | One Step pH in vitro diagnostic test REF: 31I4P | Apr 2, 2026 |
| Z-2087-2026 | Class II | One Step K in vitro diagnostic test REF: 81A4 | Apr 2, 2026 |
| Z-2086-2026 | Class II | Uric Acid in vitro diagnostic test REF: 31H0P | Apr 2, 2026 |
| Z-2088-2026 | Class II | One Step P in vitro diagnostic test REF: 8194 | Apr 2, 2026 |
| Z-2085-2026 | Class II | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | Apr 2, 2026 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 9, 2025 | Gimhae, Korea (The Republic Of) | Devices | Official Action Indicated (OAI) | 3005841640 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3005841640 | Gimhae, Korea (The Republic Of) | 1 | Jan 9, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | May 23, 2018 |
| K171521 | DUS R-50S (Urine Chemistry system) | Feb 16, 2018 |
| K102188 | CYBOW READER, MODELS 300 & 720 | Aug 9, 2011 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | Mar 29, 2006 |