FDAFDA · Food and drugs·Recall number Z-2501-2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Published September 10, 2025 · Recall initiated: October 4, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to products distributed without premarket clearance or approvals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Visgeneer, Inc.
- Distributor
- Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
- Lot
- Lot Code: Model No: eB-U01 UDI-DI: None. Lot Numbers: All lots manufactured up to Jun. 20, 2022 Serial Numbers: All lots manufactured up to Jun. 20, 2022 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2023-12-19
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Taiwan
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