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Recall Observatory FDA recall evidence

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

October 04, 2023

Class II

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

    reason.no_named_rule · v1.0.0

    Due to products distributed without premarket clearance or approvals.