Universal Meditech recalls unapproved pregnancy test strips due to lack of FDA marketing authorization and inability to verify safety documentation. Affected products were manufactured after March 2021.
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 unapproved pregnancy test strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide safety documentation, which may mean the tests could be unsafe.
The tests were distributed without FDA approval, and the manufacturer claims they cannot verify safety documentation. This means the tests might not work correctly or could be unsafe without proper quality control.
Pregnant individuals who purchased these test strips after March 2021 are likely affected. Those using the tests without FDA approval may face safety risks due to incomplete documentation.
Check for model number 100-4 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 100-4 and production dates after March 2021 on the test strips.
Universal Meditech is recalling these unapproved pregnancy test strips because they were distributed without FDA marketing authorization and the company is going out of business and cannot provide safety documentation.
The official recall record states that the manufacturer cannot verify safety documentation, so the tests may not be safe without proper quality control.
The recall record does not specify a remedy, so check the product details and contact Universal Meditech if you have concerns.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0054-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0054-2024 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.
