Z-2082-2026 Class II Ongoing
FDA device recall Z-2082-2026 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: 6533 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
- 6533 units
Product Description
One Step 10A in vitro diagnostic test
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: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905