Visgeneer Blood Uric Acid Monitoring Systems Recalled for No FDA Clearance

Agency Publication Date: September 2, 2025

Summary

Visgeneer, Inc. is recalling approximately 4,820 Blood Uric Acid Monitoring Systems because the devices were distributed without the required FDA premarket clearance or approvals. The affected kits contain a blood uric acid meter, a lancing device, a user manual, lancets, and a 10-count bottle of test strips. No incidents or injuries have been reported to date, but the accuracy and safety of these unapproved devices have not been established. Consumers should stop using the monitoring system and contact their healthcare provider or the manufacturer for further instructions.

Risk

These monitoring systems have not undergone FDA review to ensure they provide accurate and reliable blood uric acid readings. Using an unvalidated device could lead to incorrect medical results, potentially causing patients to make inappropriate treatment decisions for conditions like gout.

What You Should Do

This recall affects the Visgeneer Blood Uric Acid Monitoring System (Model eB-U01), which is sold as a kit containing a meter, lancing device, user manual, 10 lancets, and 10 test strips.
Identify affected products by looking for Model No. eB-U01 and checking for UDI-DI codes 04712558761116, 04712558761123, or 04712558761208 on the packaging.
Check the manufacture date: this recall includes all lots and serial numbers manufactured up to October 13, 2023, and test strips with expiration dates up to April 14, 2025.
Stop using the recalled monitoring system immediately.
Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Visgeneer, Inc. for further instructions.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Blood Uric Acid Monitoring System Kit

Variants: 1 meter, 1 lancing device, 10 lancets, 10 test strips

Model / REF:

eB-U01

UDI:

04712558761116

04712558761123

04712558761208

Date Ranges: All lots manufactured up to Oct. 13, 2023

Recall #: Z-2500-2025. Includes all lots and serial numbers manufactured up to Oct. 13, 2023. Firmware v1.0. Test strip expiration dates: up to 2025-04-14.

Product: Blood Uric Acid Monitoring System Kit

Variants: 1 meter, 1 lancing device, 10 lancets, 10 test strips

Model / REF:

eB-U01

Date Ranges: All lots manufactured up to Jun. 20, 2022

Recall #: Z-2501-2025. Includes all lots and serial numbers manufactured up to Jun. 20, 2022. Firmware v1.0. Test strip expiration dates: up to 2023-12-19.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97328

Status: Active

Manufacturer: Visgeneer, Inc.

Sold By: Nationwide distributors

Manufactured In: Taiwan

Units Affected: 2 products (2240; 2580)

Distributed To: California, Michigan

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects the Visgeneer Blood Uric Acid Monitoring System (Model eB-U01), which is sold as a kit containing a meter, lancing device, user manual, 10 lancets, and 10 test strips.

Identify affected products by looking for Model No. eB-U01 and checking for UDI-DI codes 04712558761116, 04712558761123, or 04712558761208 on the packaging.

Check the manufacture date: this recall includes all lots and serial numbers manufactured up to October 13, 2023, and test strips with expiration dates up to April 14, 2025.

Stop using the recalled monitoring system immediately.

Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Visgeneer, Inc. for further instructions.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information regarding this recall.

Affected Products

Product: Blood Uric Acid Monitoring System Kit

Variants: 1 meter, 1 lancing device, 10 lancets, 10 test strips

Model / REF:

eB-U01

UDI:

04712558761116

04712558761123

04712558761208

Date Ranges: All lots manufactured up to Oct. 13, 2023

Recall #: Z-2500-2025. Includes all lots and serial numbers manufactured up to Oct. 13, 2023. Firmware v1.0. Test strip expiration dates: up to 2025-04-14.

Product: Blood Uric Acid Monitoring System Kit

Variants: 1 meter, 1 lancing device, 10 lancets, 10 test strips

Model / REF:

eB-U01

Date Ranges: All lots manufactured up to Jun. 20, 2022

Recall #: Z-2501-2025. Includes all lots and serial numbers manufactured up to Jun. 20, 2022. Firmware v1.0. Test strip expiration dates: up to 2023-12-19.