FDAHealthOctober 4, 2023
Visgeneer, Inc. — Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
⚠️ Due to products distributed without premarket clearance or approvals.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 4, 2023
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
What's affected?
- 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)
- Brand
- Visgeneer, Inc.
- Lot code
- Model
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2580.
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