Blood Uric Acid Monitoring System Recall: Visgeneer Meter Kit
Announced 2025-09-10 · FDA
The FDA is recalling Visgeneer's Blood Uric Acid Monitoring System kits because they were distributed without premarket clearance or approvals. About 2,240 units distributed worldwide, including the United States (California and Michigan) and Canada, are affected, with details on lot numbers, model numbers, and kit contents (meter, lancing device, user manual, lancets, and test strips). Test strips expire by 2025-04-14 and firmware is v1.0. No corrective action is listed.
| Brand | Visgeneer, Inc. |
|---|---|
| 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) |
| Reason | Due to products distributed without premarket clearance or approvals. |
| Severity | moderate |
| Units affected | 2580 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada. |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Stop using affected kits immediately.
- Check your kit's lot and model numbers against the recall details and contact Visgeneer for return or replacement instructions.
- For more information, contact Visgeneer or consult the FDA recall page.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.