FDA Medical Device Recalls (openFDA)
Visgeneer, Inc.: 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 number
- Z-2501-2025
- Recalling firm
- Visgeneer, Inc.
- 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)
- Status
- Open, Classified
- Initiated
- 2023-10-04
- Posted
- 2025-09-02
- Terminated
- not on file
- Reason
- Due to products distributed without premarket clearance or approvals.
- Root cause
- No Marketing Application
- 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.
- Quantity
- 2580
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
- Lot, serial or model codes
- Lot Code: Model No: eB-U01 UDI-DI: None. Lot Numbers: All lots manufactured up to Jun. 20, 2022 Serial Numbers: All lots manufactured up to Jun. 20, 2022 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2023-12-19
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PTC
- Firm FEI
- 3005644014
- Firm city
- Hsinchu City
- Firm state
- not on file
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28