Universal Meditech recalls Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 due to unverified safety and lack of post-market support. 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 Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 because they are going out of business and cannot provide post-market support. The tests may not meet FDA safety standards without proper documentation.
The manufacturer claims to hold FDA 510(k) approvals but cannot verify this information. The tests may have unknown performance characteristics because the company lacks documentation showing they were manufactured safely and meet FDA standards.
Pregnancy test users who purchased the specific model numbers listed in the recall. Those who rely on the test for accurate results are most at risk.
Check for model number 100-17 on the test strip. Look for lot numbers starting with hCG-MHM-2205-01 through hCG-MHM-2210-02. The product was distributed by Universal Meditech Inc.
Verify the model number and lot numbers listed in the recall to confirm if your test is affected.
Universal Meditech is recalling the test because they are going out of business and cannot provide post-market support. The tests may not meet FDA safety standards without proper documentation.
The recall is due to the manufacturer's inability to verify FDA compliance and provide necessary documentation, but no specific safety risks are described.
Check the model number and lot numbers to see if your test is affected. If it is, contact Universal Meditech for guidance.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0049-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0049-2024 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.
