Safety Alert: Class II: Due to products distributed without premarket clearance or approvals.
healthelectronicsClass IIRecalled on Sep 10, 2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
🔢 2580
Sold At: Visgeneer, Inc.(Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.)
Recall #: FDA-DEVICE-Z-2501-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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
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Summary
Due to products distributed without premarket clearance or approvals.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Visgeneer, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.