Z-2088-2026 Class II Ongoing
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
- 1064 units
Product Description
One Step P in vitro diagnostic test REF: 8194
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:08806141302025/ Lot: 241023, 250527, 250905