Recall Z-2500-2025
Visgeneer, Inc. · initiated October 4, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: 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
Reason for recall
Due to products distributed without premarket clearance or approvals.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-2500-2025
- Initiated
- October 4, 2023
- Posted by FDA
- September 2, 2025
- Product code
- PTC – Uric Acid Test System For At Home Prescription Use
- Quantity
- 2240
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
- Recalling firm
- Visgeneer, Inc., Hsinchu City
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2501-2025 Class II | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user…Due to products distributed without premarket clearance or approvals. | 10/04/2023Open, Classified |