Z-2501-2025Class II

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

Name: Z-2501-2025 Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and...
Creator: Visgeneer, Inc.
Published: 2023-10-04
License: https://open.fda.gov/license/

Visgeneer, Inc. / initiated 2023-10-04 / Open, Classified

FDA source

Visgeneer, Inc. began a recall of Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) on 2023-10-04. FDA classified it as Class II and gives the reason as "Due to products distributed without premarket clearance or approvals". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2501-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-04
Posted: 2025-09-02
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)
Product code: PTC Uric Acid Test System For At Home Prescription Use
Reason for recall: Due to products distributed without premarket clearance or approvals.
FDA 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 in commerce: 2580
Distribution: Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2501-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2500-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2501-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02

Product code PTC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)