Universal Meditech recalls DiagnosUS Pregnancy Test Midstream REF 100-17 due to unverified quality and safety documentation. Products made after March 2021 may have unknown performance characteristics.
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 Pregnancy Test Midstream REF 100-17 because they are going out of business and cannot fulfill post-market responsibilities. The tests may have unknown safety and performance characteristics due to lack of documentation.
The tests may have unknown performance characteristics because Universal Meditech cannot provide documentation showing they were manufactured safely and effectively. The company is going out of business and cannot continue post-market responsibilities like quality checks or safety monitoring.
Pregnant individuals who purchased the DiagnosUS Pregnancy Test Midstream REF 100-17 after March 2021 are affected. Those who rely on the test for pregnancy detection may be at risk due to potential unknown performance issues.
Check for the model number 100-17 on the test strip. Products manufactured after March 2021 with lot numbers including hCG-M11-2103-01 or hCG-M11-2105-01 are affected.
Look for the model number 100-17 and lot numbers listed in the recall notice.
Universal Meditech is recalling these products because they are going out of business and cannot fulfill post-market responsibilities. They also lack documentation proving the tests were manufactured safely and effectively.
The recall states the tests may have unknown performance characteristics due to lack of documentation, but no specific safety risks like injury or illness are mentioned.
The recall does not specify a remedy, so the official notice does not say what to do with the 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-0066-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0066-2024 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.
