Universal Meditech recalls DiagnosUS hCG Pregnancy Urine Test Strips (REF 100-12) due to unverified safety 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 DiagnosUS hCG Pregnancy Urine Test Strips (REF 100-12) because they were distributed without proper FDA approval and the company is shutting down. This means the tests may not work safely or effectively as intended.
The tests were distributed without FDA marketing authorization, and Universal Meditech is shutting down. This means they lack documentation to prove the tests were made safely and work correctly, which could lead to inaccurate results or health risks.
Pregnant individuals who purchased DiagnosUS hCG Pregnancy Urine Test Strips (REF 100-12) after March 2021 are affected. Those using the tests for pregnancy detection without FDA approval may face unverified risks.
Check for the model number 100-12 on the test strip packaging. Products manufactured after March 2021 are affected, including specific lot numbers like hCG-S-2101-01 and hCG-S-2111-01-S.
Look for the model number 100-12 and lot numbers made after March 2021 on the test strip packaging.
Universal Meditech distributed these tests without FDA approval and is shutting down, so they can't provide safety documentation.
The recall record states the tests may have unknown performance characteristics due to lack of documentation.
The recall record does not specify a remedy, so check the product details and contact Universal Meditech if you have questions.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0063-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0063-2024 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.
