FDA-Device2025-09-10Class II

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

Visgeneer, Inc.
Hazard

Due to products distributed without premarket clearance or approvals.

Sold states
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Affected count
2240
Manufactured in
No. 335 Zhong Hua Rd., Sec. 6, Xiangshan Dist., Hsinchu City, N/A, Taiwan
Products
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2500-2025

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