Blood Uric Acid Monitoring System recalled for lacking FDA premarket clearance
Visgeneer's Blood Uric Acid Monitoring System kits were distributed without FDA premarket clearance. Approximately 2,240 units were distributed in California, Michigan, and Canada.
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: This is an FDA Class II recall for distribution without required premarket clearance or approvals. The source text does not identify a specific safety hazard or report any adverse events, illnesses, or injuries. The recall is based on regulatory non-compliance.
Plain-English summary
Visgeneer, Inc. is recalling Blood Uric Acid Monitoring System kits, branded as eBuricacid. Each kit contains a blood uric acid meter, a lancing device, user manual, 10 lancets, and 10 test strips in a 10-count bottle.
The recall was issued because the kits were distributed in the United States and Canada without the FDA premarket clearance or approvals that are required before medical devices can be commercially marketed. The specific FDA classification for this recall is Class II.
Approximately 2,240 units of the monitoring system were distributed nationwide in the United States, specifically in California and Michigan, as well as in Canada. The recall includes all lots manufactured up to October 13, 2023. Test strips included in the kits have expiration dates through April 14, 2025. The affected devices are identified by model number eB-U01.
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
- uncleared-device
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 (3)
- Lot Code: Model No: eB-U01 UDI-DI: (01)04712558761116 eBuricacid Meter Kit
- (01)04712558761123 eBuricacid Test Strips 25pcs
- 2023 Serial Numbers: All lots manufactured up to Oct. 13
Distribution
Distributed nationwide across the United States.
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