Visgeneer, Inc.: Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Hazard

Due to products distributed without premarket clearance or approvals.

Details from the source

Reason for recall: 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. Quantity: 2240 Lot/code info: 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

UPC codes

04712558761116, 04712558761123, 04712558761208

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.