QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | April 02, 2026 |
| Reported | May 13, 2026 |
| Recalling firm | DFI Co., Ltd. |
| Country / region | Korea (the Republic of) Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. |
Hazard
The devices were distributed without required FDA premarket clearance or approval.
Affected products
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Related recalls
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