CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
Blood Uric Acid Monitoring System Each kit contains 1 meter recalled
Visgeneer is recalling Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user, distributed nationwide in the US. The recall was initiated on 4 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2500-2025
- FDA event ID
- 97328
- Recalling firm
- Visgeneer, Hsinchu City, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2023
- FDA classified
- 2 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 4 Oct 2023 | Recall initiated by company | |
| 2 Sep 2025 | Classified by FDA | +699 days |
| 10 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to products distributed without premarket clearance or approvals.
Product as listed by the FDA
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Where it was distributed
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Questions about this recall
Why was it recalled?
Due to products distributed without premarket clearance or approvals.
Which lots are affected?
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
Where was it sold?
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97328This product is part of a recall event; the main page for the event is Blood Uric Acid Monitoring System Each kit contains 1 meter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Blood Uric Acid Monitoring System Each kit contains 1 meter recalled | Visgeneer | Other | Nationwide |
More recalls from Visgeneer
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Blood Uric Acid Monitoring System Each kit contains 1 meter recalled | Visgeneer | Other | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |