Z-2085-2026 Class II Ongoing
FDA device recall Z-2085-2026 was initiated by DFI Co., Ltd. on April 2, 2026 and is designated Class II. Reason for recall: The devices were distributed without required FDA premarket clearance or approval. The recall status is ongoing. Affected quantity: 6398 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2026
- Initiation Date
- April 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6398 units
Product Description
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Reason for Recall
The devices were distributed without required FDA premarket clearance or approval.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Code Information
UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501