Universal Meditech recalls DeTec hCG Pregnancy Urine Test Cassettes due to unverified safety and regulatory compliance issues. Products may not meet FDA standards 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 DeTec hCG Pregnancy Urine Test Cassettes because they were distributed without proper FDA approval and the company is shutting down. This means the tests might not work safely or accurately.
The company is going out of business and cannot provide documentation to prove the tests meet FDA safety and effectiveness standards. Without this, the tests may not work properly or could give incorrect results.
Pregnancy test users who purchased the DeTec hCG Pregnancy Urine Test Cassettes with lot numbers listed in the recall. Women who rely on these tests for pregnancy detection are at risk of inaccurate results.
Check for lot numbers starting with hCG-M5-2101-01 through hCG-M5-2210-02 on the test cassette packaging. The product is sold under the DeTec brand with REG Cat: 100-13.
Look for lot numbers on the test cassette packaging that match the list provided in the recall: hCG-M5-2101-01 through hCG-M5-2210-02.
Universal Meditech is recalling these pregnancy tests because they were distributed without proper FDA approval and the company is shutting down. They cannot provide documentation to ensure the tests meet safety and effectiveness standards.
Check the lot number on the packaging. If it matches the list in the recall, stop using it and contact Universal Meditech for further instructions.
The recall states that the company cannot verify the tests meet FDA standards, so they may not be safe or accurate. Do not use them until the company provides a solution.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0048-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0048-2024 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.
