Class II U.S. Food and Drug Administration

Visgeneer, Inc. Blood Uric Acid Monitoring System Each kit contains 1 meter recall: Due to products distributed without premarket clearance or approvals

Recall published 1+ years ago

Due to products distributed without premarket clearance or approvals.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to products distributed without premarket clearance or approvals.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2500-2025
Published
September 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Visgeneer, Inc.
Product type
Medical devices
Units affected
2240
Distribution
Nationwide
Made in
Taiwan
Lot / code info
Lot Code: Model No: eB-U01 UDI-DI: (01)04712558761116 eBuricacid Meter Kit, (01)04712558761123 eBuricacid Test Strips 25pcs, (01)04712558761208 eBuricacid Test Strips 10pcs*4 Lot Numbers: All lots manufactured up to Oct. 13, 2023 Serial Numbers: All lots manufactured up to Oct. 13, 2023 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2025-04-14
UPC codes
04712558761116, 04712558761123, 04712558761208

Products covered by this recall

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04712558761116
  • 04712558761123
  • 04712558761208

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2023 Software Revisions

Model or item number

On the rating label, the box or the instruction sheet.

  • eB-U01 UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • 2023

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 count

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Visgeneer, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Visgeneer, Inc. — No. 335 Zhong Hua Rd., Sec. 6, Hsinchu City

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Visgeneer, Inc. medical devices recalled?

Due to products distributed without premarket clearance or approvals. Due to products distributed without premarket clearance or approvals.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04712558761116, 04712558761123, 04712558761208; lot code 2023 Software Revisions; model number eB-U01 UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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