PlainRecalls
FDA Devices Moderate 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)

Reported: September 10, 2025 Initiated: October 4, 2023 #Z-2501-2025

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.

Details

Recalling Firm
Visgeneer, Inc.
Units Affected
2580
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Location
Hsinchu City, N/A

Frequently Asked Questions

What product was recalled?
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle). Recalled by Visgeneer, Inc.. Units affected: 2580.
Why was this product recalled?
Due to products distributed without premarket clearance or approvals.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2501-2025.