Universal Meditech recalls HealthyWiser UriTest 10-Parameter Reagent Test Strips (REF 900-10) due to unverified safety and lack of post-market support as the company goes out of business.
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 UriTest 10-Parameter Reagent Test Strips because the company is going out of business and cannot fulfill post-market responsibilities. These test strips may not meet safety and effectiveness standards without proper documentation.
The company is going out of business and cannot provide necessary safety documentation or post-market support. Without verified manufacturing records and quality control, the test strips may not perform as intended.
Users of HealthyWiser UriTest strips who purchased them from 2021-2022 are affected. Those who rely on these strips for urinalysis testing are most at risk.
Check for model number 900-10 on the strip packaging. Lot numbers include URS-1-2104-01, URS-1-2102-02, URS-1-2105-01, URS-1-2106-02, and URS-1-2110-02.
Look for model number 900-10 and lot numbers listed above on the packaging.
Universal Meditech is going out of business and cannot fulfill post-market responsibilities for these test strips, which lack verified safety documentation.
The recall is due to the company's inability to provide necessary safety documentation and post-market support, not an immediate safety hazard.
The official recall does not specify a remedy, so check the product details and contact Universal Meditech if you have questions.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0044-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0044-2024 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.
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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.
