Universal Meditech recalls Lem Fertility LH Ovulation Test strips (REF 200-07) due to unverified safety and lack of post-market documentation. Products made after March 2021 may be unsafe without proper regulatory compliance.
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 Lem Fertility LH 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 tests might not work safely or effectively without documented quality control.
The company is going out of business and cannot provide proof that the tests were made safely or work as intended. Without regulatory documentation, the tests might not be accurate or could pose health risks.
Anyone who owns or uses the Lem Fertility LH Ovulation Test strips (REF 200-07) made after March 2021. Women trying to track ovulation may be at risk if the test is inaccurate or unsafe.
Check for the model number 200-07 on the strip. Products made after March 2021, including lot numbers starting with LH-S-2112-01, are affected.
Look for the model number 200-07 and lot numbers made after March 2021, including LH-S-2112-01.
Universal Meditech is going out of business and cannot provide proof that the tests were made safely or work as intended. The company claims to have FDA approvals but has not been able to verify this information.
The recall record states that the tests may have unknown performance characteristics because the company cannot provide documentation of proper manufacturing and safety checks.
The recall record does not specify a remedy, so you should check the product details and consider contacting Universal Meditech if you have concerns.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0062-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0062-2024 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.
