Blood Uric Acid Monitoring System recallZ-2500-2025 · Visgeneer, Inc. · initiated Oct 4, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Visgeneer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to products distributed without premarket clearance or approvals.
FDA root cause category: No Marketing Application
What the company is doing
On 12/04/2023, the firm sent an email titled, "FDA notification about eBuricacid" to its distibutors informing them that Visgeneer has received a notice from FDA that the eBuricacid/Uritouch Blood uric acid monitors are not cleared to be marketed/distributed within the U.S. and is requesting that the products (kits and strips) be delisted from Amazon site as soon as possible. An additional email was sent to distributors on 06/23/2025 and 07/01/2025 as a follow up to the 12/04/2023 email - requesting for information on the quantities of monitors/kits and strips that were removed from Amazon, and instructing the distributor to destroy the stock of affected products on hand and noting that the strips are expired.
Recall details
- Recall number
- Z-2500-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 4, 2023
- Posted by the FDA
- Sep 2, 2025
- Recalling firm
- Visgeneer, Inc.
- Quantity
- 2240
- Product code
- PTC
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
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)
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- eBuricacid eB-U01Visgeneer, Inc. · Acid, Uric, Uricase (Oxygen Rate)1 recall0 reports
- eBuricacidVisgeneer, Inc. · Acid, Uric, Uricase (Oxygen Rate)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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