Universal Meditech recalls DiagnosUS SARS-CoV-2 Antibody tests due to unverified manufacturing and lack of post-market documentation. Products made after March 2021 may have unknown safety and effectiveness.
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 DiagnosUS SARS-CoV-2 antibody tests because they were distributed without proper FDA approval and the company is going out of business. These tests may not work correctly or be safe without proper documentation.
The tests were distributed without FDA marketing authorization and the manufacturer is going out of business. Without proper documentation, the tests may not work correctly or be safe for use, potentially leading to incorrect results or health risks.
Anyone who purchased DiagnosUS SARS-CoV-2 antibody tests made after March 2021. People using these tests for medical purposes without proper verification are at risk.
Check for model number 555-10 on the test strips. Products manufactured after March 2021 with lot numbers including COV-UL-2208-01 are affected.
Look for model number 555-10 and lot numbers made after March 2021, including COV-UL-2208-01.
Universal Meditech distributed these tests without FDA approval and is going out of business, so they can't provide post-market safety documentation.
The recall states the tests may have unknown performance characteristics due to lack of documentation, so they are not safe for use without verification.
The recall doesn't specify a remedy, so check with Universal Meditech or the FDA for guidance.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0059-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0059-2024 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.
