Universal Meditech Inc. recalls HealthyWiser KetoFast Ketone Test Strips REF 900-1K due to unverified manufacturing compliance and lack of post-market documentation. Consumers should check product details and contact the company for updates.
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 KetoFast Ketone Test Strips because they were distributed without proper FDA approval and the company is going out of business. This means the test strips may not work safely or effectively as intended.
The company claims to have 510(k) approvals but FDA cannot verify this. The test strips may have unknown performance issues because the company lacks documentation showing they were made safely and meet quality standards.
Owners of HealthyWiser KetoFast Ketone Test Strips REF 900-1K (150 strips) are affected. People using these strips for ketone testing are at risk if the product doesn't function properly.
Check for model number 900-1K and lot number URS-1-2104-02 on the product packaging. The product was sold by Universal Meditech Inc. and is part of a recall due to the company going out of business.
Look for model number 900-1K and lot number URS-1-2104-02 on the packaging to confirm if the product is recalled.
Universal Meditech Inc. is recalling these test strips because they were distributed without proper FDA approval and the company is going out of business and cannot fulfill post-market responsibilities.
The recall is due to the company going out of business, so there is no fix or remedy provided.
Check for model number 900-1K and lot number URS-1-2104-02 on the packaging.
We’ve drafted a message you can send HealthyWiser to request your refund or repair — edit it as you like.
Subject: Recall Z-0046-2024 — HealthyWiser HealthyWiser Hello, I own a HealthyWiser that is covered by recall Z-0046-2024 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.
