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U.S. Department of Health and Human Services

Class 2 Device Recall eBuricacid

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 Class 2 Device Recall eBuricacidsee related information
Date Initiated by FirmOctober 04, 2023
Date PostedSeptember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2500-2025
Recall Event ID 97328
Product Classification Uric acid test system for at home prescription use - Product Code PTC
ProductBlood 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 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
Recalling Firm/
Manufacturer		 Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan
For Additional Information ContactRyan Tai
886-3-5181918 Ext. 1690
Manufacturer Reason
for Recall		Due to products distributed without premarket clearance or approvals.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce2240
DistributionWorldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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