FDA Device recall Z-2500-2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle) by Visgeneer, citing due to products distributed without premarket clearance or approvals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2500-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Visgeneer |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: Model No: eB-U01 UDI-DI: (01)04712558761116 eBuricacid Meter Kit, (01)04712558761123 eBuricacid Test Strips 2…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2500-2025%22
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