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Open, Classified

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

FDA Recall Z-2501-2025 · Posted 2025-09-02

Recalling FirmVisgeneer, Inc.
Recall StatusOpen, Classified
Product CodePTC
Date Initiated2023-10-04
Product Quantity2580

Reason for Recall

Due to products distributed without premarket clearance or approvals.

Firm Action

On 12/04/2023, the firm sent an email titled, "FDA notification about eBuricacid" to its distibutors informing them that Visgeneer has received a notice from FDA that the eBuricacid/Uritouch Blood uric acid monitors are not cleared to be marketed/distributed within the U.S. and is requesting that the products (kits and strips) be delisted from Amazon site as soon as possible. An additional email was sent to distributors on 06/23/2025 and 07/01/2025 as a follow up to the 12/04/2023 email - requesting for information on the quantities of monitors/kits and strips that were removed from Amazon, and instructing the distributor to destroy the stock of affected products on hand and noting that the strips are expired.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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