Universal Meditech recalls DiagnosUS One Step FSH Menopausal Test strips (REF 210-07) due to unverified manufacturing compliance and lack of post-market documentation. All units made after March 2021 are affected.
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 DiagnosUS One Step FSH Menopausal Test strips because they were distributed without proper FDA approval and the company can't prove they were made safely. This means the test might not work correctly or could be unsafe without proper documentation.
The manufacturer claims they distributed these tests without FDA approval and cannot provide proof that the products were made safely or meet quality standards. Without documentation of proper manufacturing, storage, or post-market safety monitoring, the tests might not work correctly or could pose health risks.
Women who purchased the DiagnosUS One Step FSH Menopausal Test strips (model 210-07) after March 2021 are affected. Those using the test for medical purposes without proper verification are at higher risk.
Check for the model number 210-07 on the test strip. Products manufactured after March 2021 are affected, including specific lot numbers like FSH-S-2106-01, FSH-S-2108-01, and FSH-S-2111-01-S.
Look for the model number 210-07 and lot numbers made after March 2021 on the test strip.
Universal Meditech distributed these tests without FDA approval and cannot provide proof they were made safely or meet quality standards.
The recall is due to unverified manufacturing compliance and lack of post-market documentation, but specific safety risks are not clearly stated.
The official recall notice does not specify a remedy, so contact Universal Meditech directly 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-0060-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0060-2024 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.
