The Recall Desk
HighFDA (Devices)·Z-2501-2025·Announced 2025-09-10

Blood Uric Acid Monitoring System Recalled for Lack of FDA Premarket Approval

Visgeneer, Inc. is recalling Blood Uric Acid Monitoring System kits distributed without FDA premarket approval in the U.S. and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is classified as FDA Class II with no reported illnesses, injuries, or deaths. The hazard is regulatory non-compliance (lack of premarket approval), which represents a risk-of-harm because the device's safety and effectiveness have not been verified by the FDA. Per the rubric, when illnesses/injuries are not reported but the product presents a theoretical risk of harm, the score is at most 3. The High severity reflects the inherent risk in an unapproved medical device.

Plain-English summary

Visgeneer, Inc. is recalling all Blood Uric Acid Monitoring System kits distributed in the United States and Canada. The recall affects units distributed without FDA premarket clearance or approval. The system is designed to monitor blood uric acid levels and includes a meter, lancing device, lancets, and test strips.

The kits affected include all units manufactured up to June 20, 2022, and were distributed nationwide in California and Michigan, as well as in Canada. Test strips with expiration dates up to December 19, 2023, are affected.

Consumers who have this product should stop using it. Contact Visgeneer, Inc. for instructions on how to return or dispose of the device. Because the device was not approved through the FDA premarket review process, its safety and effectiveness have not been verified by the agency.

The recalled product

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)
Manufacturer
Visgeneer, Inc.
Category
Medical Device — Blood Testing / Monitoring
Hazard
  • unapproved-device
  • regulatory-non-compliance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 2022 Serial Numbers: All lots manufactured up to Jun. 20

Distribution

Distributed nationwide across the United States.

Related recalls

Same category