Universal Meditech recalls Lem Fertility hCG Pregnancy Urine Test REF 100-12 due to unverified quality and safety documentation. Products made after March 2021 may have unknown performance risks.
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 Lem Fertility hCG Pregnancy Urine Test REF 100-12 because they are going out of business and cannot fulfill post-market responsibilities. The tests may not meet safety and effectiveness standards due to lack of documentation.
The manufacturer claims to hold FDA 510(k) approvals but cannot provide documentation proving the tests were manufactured safely or meet quality standards. Without proper documentation, the tests might not work correctly or could pose safety risks.
Pregnancy test users who purchased the Lem Fertility hCG Pregnancy Urine Test REF 100-12 after March 2021 are affected. Women using these tests for pregnancy detection are at risk if the tests do not function as intended.
Check for the model number 100-12 on the test strip. Products manufactured after March 2021 with lot numbers including hCG -S-2112-02 are affected.
Look for the model number 100-12 and lot numbers including hCG -S-2112-02 on the test strip.
Universal Meditech is recalling these tests because they are going out of business and cannot fulfill post-market responsibilities. The company cannot provide documentation proving the tests meet safety and effectiveness standards.
The recall record states the tests may have unknown performance characteristics due to lack of documentation. Safety cannot be confirmed.
The recall record does not specify a remedy, so there is no action required beyond checking if you have the affected product.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0061-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0061-2024 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.
