Universal Meditech recalls unapproved PrestiBio test strips due to lack of FDA marketing authorization and inability to verify safety documentation. Products made after March 2021 are affected.
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 PrestiBio test strips because they were distributed without FDA approval. The company is going out of business and cannot provide safety documentation, making these products potentially unsafe.
The test strips were distributed without FDA approval and Universal Meditech cannot verify they were made safely. The company is going out of business and won't provide safety documentation or fix issues, so the products may not work correctly or could be unsafe.
Anyone who owns or uses these test strips, especially those who rely on them for medical testing. People using the strips for breast milk alcohol, SARS-CoV-2 antibodies, or ketone levels are most at risk.
Check for model number 900-10 on the test strips. Products manufactured after March 2021 are affected. There is no unique identifier (UDI-DI code) for these products.
Look for model number 900-10 and production dates after March 2021 on the test strips.
Universal Meditech distributed these test strips without FDA approval and is going out of business, so they can't provide safety documentation or fix issues.
The recall record states the products may have unknown safety characteristics because Universal Meditech cannot verify they were made safely.
The recall record 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-0057-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0057-2024 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.
