Device 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)
Z-2501-2025
Product summary
- Firm
- Visgeneer, Inc.
- Event
- Event 97328
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2580
- Official record key
device-enforcement:Z-2501-2025
Official wording
Reason: Due to products distributed without premarket clearance or approvals.
Code information: 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 pattern: Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.
Derived failure modes
-
Unknown
Due to products distributed without premarket clearance or approvals.