Medical device recalls Moderate risk

Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str…

Recall date
October 4, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2501-2025
FDA classification
Class II
Brand / firm
Visgeneer, Inc.
Sold / distributed
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.

Why it was recalled

Due to products distributed without premarket clearance or approvals.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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)

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