Universal Meditech recalls PrestiBio breastmilk alcohol test strips (model 910-10) due to lack of FDA verification and potential safety risks. All units 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 breastmilk alcohol test strips (model 910-10) because they were distributed without proper FDA authorization and the company is going out of business. This means the test strips may not be safe or effective as intended.
The test strips were distributed without FDA approval and the manufacturer is going out of business. This means they may not meet safety standards and could be ineffective or unsafe for use.
Mothers who use these test strips for breastmilk alcohol testing are likely affected. Those who purchased the strips after March 2021 are at risk due to the company's inability to provide safety documentation.
Check for the model number 910-10 on the test strips. Products manufactured after March 2021 are affected. There is no unique identifier (UDI-DI code) for these products.
Look for the model number 910-10 and check if the product was manufactured after March 2021.
Universal Meditech is recalling these test strips because they were distributed without FDA authorization and the company is going out of business, making it impossible to provide safety documentation.
The recall indicates potential safety risks due to the manufacturer's inability to verify the products meet safety standards, but specific hazards are not clearly described.
The recall does not specify a remedy, so you should check the product date and model number to determine if it's affected. If it was made after March 2021, it is part of the recall.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0051-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0051-2024 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.
