Z-2084-2026 Class II Ongoing
FDA device recall Z-2084-2026 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: 7860 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
- 7860 units
Product Description
One Step pH in vitro diagnostic test REF: 31I4P
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: 250305, 250415, 250509, 250625, 250905