Home / Recalls / Visgeneer, Inc. / Z-2501-2025

Z-2501-2025 Class II Ongoing

Recalled by Visgeneer, Inc. — Hsinchu City, N/A

Recall Details

Product Type: Devices
Report Date: September 10, 2025
Initiation Date: October 4, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2580

Product Description

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Reason for Recall

Due to products distributed without premarket clearance or approvals.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.

Code Information

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