Hsinchu City, N/A, Taiwan
Visgeneer, Inc. recalls
1 recall recorded since 2018, most recently on 4 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 October 2023
- Reason
- Due to products distributed without premarket clearance or approvals.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2501-2025, 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)
- Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.