FDA recall Z-2500-2025

Visgeneer, Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-10-04
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hsinchu City, N/A, Taiwan

Primary source

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