Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test stri

FDA device recall Z-2501-2025 · posted 2025-09-02 · Open, Classified

Recall details

Recalling firm

Visgeneer, Inc.

Reason for recall

Due to products distributed without premarket clearance or approvals.

Action taken

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

Status

Open, Classified

Product code

PTC

Quantity affected

2580

Distribution

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

Date initiated

2023-10-04

Date posted

2025-09-02

Location

Hsinchu City, Taiwan