Universal Meditech recalls PrestiBio Ovulation and Pregnancy Strips (REF 100-4, 200-4) sold after March 2021 due to lack of FDA verification and potential safety risks. Consumers should contact the company for details.
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 and Pregnancy Strips (REF 100-4 and 200-4) sold after March 2021 because the company is going out of business and cannot fulfill post-market responsibilities. These products may not meet safety standards without proper documentation.
The company is going out of business and cannot provide necessary safety documentation or post-market support. Without verified manufacturing records and quality control, these tests may not work correctly or could pose safety risks.
Pregnant women and individuals using ovulation/pregnancy test strips who bought them after March 2021 are likely affected. Those who rely on these tests for health monitoring are at higher risk.
Check for model numbers 100-4 or 200-4 on the strips. Products manufactured after March 2021 are affected.
Reach out to the company for specific instructions on handling the recalled products.
Universal Meditech is going out of business and cannot fulfill post-market responsibilities for these products, which may lack proper safety documentation.
The recall indicates potential safety risks due to the company's inability to provide necessary documentation and quality control records.
Contact Universal Meditech directly for specific instructions on handling the recalled products.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0053-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0053-2024 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.
