Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test str
Summary
The FDA issued a Class II for Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, by Visgeneer, Inc.. Reason: Due to products distributed without premarket clearance or approvals..
Details
Source
Device Recall
External ID
Z-2501-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Lot/Code Info: 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
Quantity Affected: 2580
Reason for Recall
Due to products distributed without premarket clearance or approvals.
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-04
Company
Hsinchu City, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Visgeneer, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Visgeneer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Visgeneer, Inc. have FDA actions?
Visgeneer, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2501-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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