Universal Meditech recalls DiagnosUS One Step LH Ovulation Test Strips (REF 200-07) due to unverified safety and regulatory compliance. 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 DiagnosUS One Step LH Ovulation Test Strips (REF 200-07) because they were distributed without proper FDA authorization and the company is going out of business. This means the test strips may not be safe or effective without documented quality control.
The manufacturer claims to have 510(k) approvals but FDA cannot verify this. The test strips lack documentation proving they were made safely and consistently, which could lead to inaccurate results or health risks.
Women who use ovulation test strips to track fertility may be affected. Those who purchased these strips after March 2021 are most at risk due to unverified safety.
Check for the model number 200-07 on the test strip. Products manufactured after March 2021 include lot numbers like LH-S-2204-01-S and LH-S-2111-01-S.
Look for the model number 200-07 and lot numbers made after March 2021.
Universal Meditech is recalling these test strips because they were distributed without FDA authorization and the company is going out of business, making it impossible to provide post-market safety support.
The manufacturer claims they have 510(k) approvals but FDA has been unable to verify this information, so safety and effectiveness cannot be confirmed.
The recall does not specify a remedy, so check the product details to see if it was made after March 2021 and contact Universal Meditech for guidance.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0058-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0058-2024 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.
