BEUDAMED
    FDA Recall 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)

    Recall: Z-2500-2025 · Initiated October 4, 2023

    Recall

    Recall Number
    Z-2500-2025
    Event Number
    97328
    Firm
    Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan
    FEI Number
    3005644014
    Product Code
    PTC
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    October 4, 2023
    Posted
    September 2, 2025

    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

    Due to products distributed without premarket clearance or approvals.

    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.

    Distribution

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

    Quantity

    2240