Uric acid monitoring kits recalled over missing premarket clearance or approval
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is a regulatory clearance gap rather than any defect described in the product.
Plain-English summary
The Blood Uric Acid Monitoring System, model eB-U01, is being recalled. Each kit contains one meter, one lancing device, a user manual, 10 lancets and 10 test strips in a 10-count bottle. No UDI-DI is listed for this group; it covers all lots manufactured up to June 20, 2022, with serial numbers listed in the recall notice. The recall covers 2,580 units distributed in California and Michigan and in Canada.
The recall was issued because the products were distributed without premarket clearance or approvals. The FDA classified the action as Class II. The notice does not describe a defect in the devices.
Holders of affected kits should follow the manufacturer's instructions for return.
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.
- Hazard
- regulatory-clearance
- unapproved-device
- class-ii
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.
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