Universal Meditech recalls Ovulation Test Strips REF 200-07 due to unverified safety and lack of post-market support. Products made after March 2021 may pose risks without proper documentation.
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 Ovulation Test Strips (REF 200-07) because they were distributed without proper FDA approval and the company is going out of business. This means the test strips may not be safe or effective without ongoing support from the manufacturer.
The test strips were distributed without FDA marketing authorization and the manufacturer is going out of business. This means they lack necessary safety documentation and post-market monitoring, which could lead to unreliable results or health risks.
Women who use ovulation test strips from Universal Meditech may be affected. Those who purchased the product after March 2021 are most at risk due to the lack of post-market support.
Check for the model number 200-07 on the test strips. Products manufactured after March 2021, including lot numbers starting with LH-S-2108-01, are affected.
Look for the model number 200-07 and lot numbers starting with LH-S-2108-01 on the test strips.
Universal Meditech is recalling the test strips because they were distributed without FDA marketing authorization and the company is going out of business, meaning they cannot provide post-market support or safety documentation.
The recall indicates potential safety risks due to unverified performance characteristics and lack of post-market monitoring, but specific risks like injury are not detailed in the official notice.
Check the product details to see if it matches the affected model and lot numbers. If it does, contact Universal Meditech for guidance, though the recall does not specify a remedy.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0068-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0068-2024 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.
