Recall Z-2500-2025 ยท PTC Uric Acid Test System For At Home Prescription Use
Visgeneer, Inc.
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
| Date | Sep 2, 2025 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| Reason | Due to products distributed without premarket clearance or approvals. |
| Root cause | No Marketing Application |
| Action | 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, |
| Quantity | 2240 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.