Universal Meditech recalls DiagnosUS hCG Pregnancy Test Cassette Format REF 100-27 due to unverified safety and regulatory compliance. 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 Test Cassette Format REF 100-27 because the company is going out of business and cannot fulfill post-market responsibilities. This recall affects all units manufactured after March 2021, which may lack proper safety documentation.
The recall is due to Universal Meditech going out of business and being unable to provide necessary safety documentation. The company claims to hold 510(k) approvals but FDA has not verified this information. Without proper documentation, the test may not perform safely or effectively.
Pregnancy test users who purchased the DiagnosUS hCG Pregnancy Test Cassette Format REF 100-27 after March 2021 are affected. Those who used the product without verifying the manufacturer's compliance may be at risk.
Check for the model number 100-27 on the test cassette. Products manufactured after March 2021 with lot numbers including hCG-M5-2106-03 are affected.
Look for model number 100-27 and lot numbers made after March 2021, including hCG-M5-2106-03.
Universal Meditech is going out of business and cannot fulfill post-market responsibilities for these products, which may lack proper safety documentation.
The recall is due to the company being unable to provide necessary documentation, but specific safety risks are not clearly described in the notice.
Check for model number 100-27 and lot numbers made after March 2021, including hCG-M5-2106-03.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0065-2024 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.
