Universal Meditech recalls One Step Ovulation Test REF 200-01 due to unverified safety and regulatory compliance issues. The company is going out of business and cannot fulfill post-market responsibilities.
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 their One Step Ovulation Test REF 200-01 because they are going out of business and cannot provide safety documentation. This recall is due to unverified regulatory compliance and potential safety risks from the product.
The product was distributed without proper regulatory authorization. Universal Meditech claims to hold 510(k)s but FDA cannot verify this. The company is going out of business and cannot provide safety documentation or post-market surveillance.
Users of the One Step Ovulation Test REF 200-01 are affected. Pregnant women and those using the test for fertility tracking may be at higher risk due to the product's unverified safety.
Check for the model number 200-01 on the test strip. Look for lot numbers 3-L12121-20UMI or 3-L07102-20UMI. The product was sold by Universal Meditech.
Verify the model number (200-01) and lot numbers (3-L12121-20UMI or 3-L07102-20UMI) on the test strip.
Universal Meditech is going out of business and cannot fulfill post-market responsibilities, so they are recalling the product due to unverified regulatory compliance.
The recall is due to unverified regulatory compliance and potential safety risks, but specific injury risks are not described in the official notice.
The official notice does not specify a remedy, so you should check the product details and contact Universal Meditech if you have questions.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0043-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0043-2024 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.
