FDA Medical devices recall ·
Blood Uric Acid Monitoring System Each kit contains 1 meter… recall
- Recall number
- Z-2501-2025
- Date
- (initiated October 4, 2023)
- Company / brand
- Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6, Hsinchu City, N/A, Taiwan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2580
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Due to products distributed without premarket clearance or approvals.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No: eB-U01 UDI-DI: None. Lot Numbers: All lots manufactured up to Jun. 20, 2022 Serial Numbers: All lots manufactured up to Jun. 20, 2022 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2023-12-19
Distribution
Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
States: California Michigan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2501-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.