Visgeneer recalls blood uric acid monitoring kits distributed without FDA premarket approval. Affected kits have specific model numbers and production dates. Consumers should contact the company for details.
Due to products distributed without premarket clearance or approvals.
Visgeneer is recalling blood uric acid monitoring kits that were sold without FDA premarket approval. This means the devices may not be safe for medical use and could pose health risks if used improperly.
The devices were distributed without FDA premarket clearance or approval, meaning they haven't been tested for safety and effectiveness. This could lead to inaccurate test results or potential health risks if used without proper medical oversight.
People who own or use the Visgeneer Blood Uric Acid Monitoring System kits with model numbers eB-U01 and production dates up to October 13, 2023, are affected. Those with the kit are most at risk.
Check for model number eB-U01 on the kit, production dates up to October 13, 2023, and lot numbers listed in the product description. The kit includes a meter, lancing device, user manual, 10 lancets, and 10 test strips.
Visgeneer will provide details on how to return or dispose of the kit if you have it.
The kit was distributed without FDA premarket clearance or approval, meaning it hasn't been tested for safety and effectiveness.
Model number eB-U01, production dates up to October 13, 2023, and lot numbers listed in the product description.
Check for model number eB-U01, production dates up to October 13, 2023, and lot numbers listed in the product description.
We’ve drafted a message you can send Visgeneer to request your refund or repair — edit it as you like.
Subject: Recall Z-2500-2025 — Visgeneer Visgeneer Hello, I own a Visgeneer that is covered by recall Z-2500-2025 from Visgeneer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
