[Recalled] HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 — Universal Meditech Inc | FDA 2023-05-22

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Universal Meditech Inc.

• DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 — Class II
• PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS — Class II
• PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 — Class II
• DiagnosUS Pregnancy Test Midstream REF 100-17 — Class II
• PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE — Class II
• Lem Fertility hCG Pregnancy Urine Test REF 100-12 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.