Reported Sep 10, 2025 · Ongoing
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test…
Visgeneer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Visgeneer, Inc. · No. 335 Zhong Hua Rd., Sec. 6 · Hsinchu City, N/A · N/A
Is this the product you have?
- 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 codes and dates
- Lot CodeModel
- NoeB-U01
- UDI-DINone
- Lot Numbers
All lots manufactured up to Jun. 202022
- Serial Numbers
All lots manufactured up to Jun. 202022
- Software RevisionsFirmware v1.0
- Expiration DatesTest
- stripsup to 2023-12-19
- Amount recalled
- 2580
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to products distributed without premarket clearance or approvals.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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