Universal Meditech Inc. recalls HealthyWiser UTI Test Strips (REF 900-UTI) due to lack of FDA approval and unverified quality control. Consumers should stop using these unapproved tests to avoid potential safety risks.
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 Inc. is recalling HealthyWiser UTI Test Strips (REF 900-UTI) because they were distributed without FDA approval. The tests may not meet safety and effectiveness standards due to the company's inability to provide required documentation.
The tests were distributed without FDA approval and the manufacturer cannot provide proof they were made safely or effectively. Without proper documentation, the tests might not work correctly or could cause harm.
Anyone who owns or uses HealthyWiser UTI Test Strips (REF 900-UTI) from the listed lot numbers. People using these unapproved tests for medical purposes are at risk due to potential safety issues.
Check for the model number 900-UTI on the test strips. Look for lot numbers: URS-1-2102-03, URS-1-2106-01, URS-1-2202-01-Q, URS-1-2204-01, or URS-1-2207-01.
Immediately stop using HealthyWiser UTI Test Strips (REF 900-UTI) from the listed lot numbers as they were distributed without FDA approval.
Universal Meditech Inc. is recalling these test strips because they were distributed without FDA approval and the company cannot provide required documentation to ensure safety and effectiveness.
Lot numbers: URS-1-2102-03, URS-1-2106-01, URS-1-2202-01-Q, URS-1-2204-01, and URS-1-2207-01.
Yes, you should stop using these test strips immediately as they were distributed without FDA approval.
We’ve drafted a message you can send HealthyWiser to request your refund or repair — edit it as you like.
Subject: Recall Z-0045-2024 — HealthyWiser HealthyWiser Hello, I own a HealthyWiser that is covered by recall Z-0045-2024 from HealthyWiser. 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.
