company
DFI Co., Ltd.
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: One Step pH in vitro diagnostic test REF: 31I4P
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: Uric Acid in vitro diagnostic test REF: 31H0P
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: One Step 10A in vitro diagnostic test
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: One Step K in vitro diagnostic test REF: 81A4
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: One Step P in vitro diagnostic test REF: 8194
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: One Step UTI in vitro diagnostic test REF: 3374
- fda_recall · device_recall2026-05-13DFI Co., Ltd. — Class II recall: QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Frequently asked questions
- How many FDA warning letters has DFI Co., Ltd. received?
- Argus HQ has not recorded an FDA warning letter for DFI Co., Ltd. in our current dataset.
- What FDA recalls has DFI Co., Ltd. issued?
- Argus HQ has recorded 7 FDA recalls tied to DFI Co., Ltd..
- Is DFI Co., Ltd. FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 7 recalls, and 0 approval records for DFI Co., Ltd.. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.