Universal Meditech recalls PrestiBio Ovulation Strips (REF 200-4) due to unverified safety and lack of post-market support. 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 Ovulation Strips (REF 200-4) because they were distributed without proper FDA approval and the company is shutting down. This means the test strips may not work safely or effectively, and the company can't provide ongoing support.
The company claims to have FDA approval but cannot prove it. Without proper documentation, the test strips might not work correctly or could be unsafe. Since the company is closing, they won't fix issues or provide updates.
PrestiBio Ovulation Strips users who bought the product after March 2021 are affected. People using these strips for pregnancy testing may face safety risks due to unverified performance.
Check for model number 200-4 on the strip packaging. Products made after March 2021 are affected. There is no unique identifier (UDI-DI code) for these strips.
Look for the model number 200-4 and check if the product was made after March 2021.
Universal Meditech claims to have FDA approval but cannot provide proof of manufacturing compliance or post-market support. The company is shutting down and cannot fulfill ongoing responsibilities.
Check if the product was made after March 2021. If so, stop using it and contact Universal Meditech for guidance.
The recall is due to the company closing and not being able to provide support. There is no fix for the product itself.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0052-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0052-2024 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.
