FDA Enforcement
Class II
Ongoing
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Recall: Z-2501-2025
·
Reported September 10, 2025
Enforcement
- Recall Number
- Z-2501-2025
- Event ID
- 97328
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Visgeneer, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2025
- Initiation Date
- October 4, 2023
- Classification Date
- September 2, 2025
- Address
- No. 335 Zhong Hua Rd., Sec. 6, Xiangshan Dist., Hsinchu City, N/A, N/A, Taiwan
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
Due to products distributed without premarket clearance or approvals.
Code Info
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
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Quantity
2580