Universal Meditech recalls HealthyWiser pH test strips due to unverified safety and regulatory compliance issues. The company is going out of business and cannot fulfill post-market responsibilities.
Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS¿ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
Universal Meditech is recalling HealthyWiser pH test strips because they were distributed without proper regulatory approval and the company is going out of business. This means the test strips may not be safe or effective as intended.
The test strips were distributed without marketing authorization from the FDA. Universal Meditech claims to hold 510(k) approvals but cannot verify this information. The company is going out of business and cannot provide safety documentation or post-market monitoring.
Users of HealthyWiser pH test strips with model number 900-1P are affected. Those who rely on these strips for medical testing face potential safety risks due to the company's inability to provide necessary documentation.
Check for model number 900-1P on the test strips. Lot numbers include URS-1-2105-01-Q through URS-1-2111-01-Q. The product was sold by Universal Meditech.
Reach out to Universal Meditech for guidance on next steps since they are going out of business and cannot fulfill post-market responsibilities.
Universal Meditech is recalling the test strips because they were distributed without proper regulatory approval and the company is going out of business, making it impossible to provide safety documentation or post-market monitoring.
The recall record states that the test strips may have unknown performance characteristics due to the company's inability to provide necessary documentation.
Contact Universal Meditech for guidance as they are going out of business and cannot fulfill post-market responsibilities.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0047-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0047-2024 from Universal Meditech. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
