Recall Z-2500-2025— Visgeneer, Inc.
Class II · Ongoing
Class II FDA medical device recall by Visgeneer, Inc., initiated 2023-10-04. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Visgeneer, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-04
- Firm location
- Hsinchu City, N/A, Taiwan
Product description
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 for recall
Due to products distributed without premarket clearance or approvals.
Data sourced from openFDA. This site is unofficial and independent of the FDA.