Visgeneer recalls all Blood Uric Acid Monitoring Systems sold without FDA premarket clearance due to unapproved distribution. No remedy provided in official notice.
Due to products distributed without premarket clearance or approvals.
Visgeneer is recalling all Blood Uric Acid Monitoring Systems sold up to June 20, 2022, because they were distributed without FDA approval. This means the product may not be safe for use as intended.
The product was distributed without FDA premarket clearance or approval. This means the device may not meet safety standards and could pose risks if used without proper regulatory oversight.
People who own or use the Blood Uric Acid Monitoring System with model eB-U01, manufactured up to June 20, 2022, are affected. Those who rely on this device for medical testing are at higher risk.
Check for the model number eB-U01 on the device. The product was manufactured up to June 20, 2022, and includes 10 test strips with an expiration date of December 19, 2023.
Look for the model number eB-U01 and manufacturing date up to June 20, 2022.
The official recall notice does not provide a remedy.
Check for model number eB-U01 and manufacturing date up to June 20, 2022.
The official recall notice does not specify a remedy.
We’ve drafted a message you can send Visgeneer to request your refund or repair — edit it as you like.
Subject: Recall Z-2501-2025 — Visgeneer Visgeneer Hello, I own a Visgeneer that is covered by recall Z-2501-2025 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.
