Z-2087-2026 Class II Ongoing
FDA device recall Z-2087-2026 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: 761 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
- 761 units
Product Description
One Step K in vitro diagnostic test REF: 81A4
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:08806141302650/ Lot: 241023, 250625, 250905