Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
This recall is currently active, issued September 2, 2025. It was issued by Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan.
- Recall Initiated
- October 4, 2023
- Posted
- September 2, 2025
- Recall Number
- Z-2501-2025
- Quantity
- 2580
- Official Source
- View on FDA website ↗
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.
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
Root 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.