Universal Meditech recalls One Step Pregnancy Test REF 100-01 due to unverified safety and regulatory compliance issues. The company is going out of business and cannot fulfill post-market responsibilities.
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 their One Step Pregnancy Test REF 100-01 because they are going out of business and cannot provide safety documentation. This recall happens because the company claims to hold FDA approvals but has not proven the tests were made safely or properly.
The tests may have unknown performance characteristics because Universal Meditech cannot provide proof they were made safely or properly. The company is going out of business and cannot fulfill post-market responsibilities like safety monitoring or documentation.
Pregnancy test users who purchased the One Step Pregnancy Test REF 100-01 from Universal Meditech. Those who rely on these tests for accurate results are most at risk due to potential safety issues.
Check for the model number 100-01 on the test packaging. Look for lot numbers 3-H25052-20UMI or 3-H07102-20UMI. The product was sold by Universal Meditech.
Look for the model number 100-01 and lot numbers 3-H25052-20UMI or 3-H07102-20UMI on the test packaging.
Universal Meditech is going out of business and cannot fulfill post-market responsibilities for these tests. They also cannot provide proof the tests were made safely or properly.
The recall states the tests may have unknown performance characteristics because Universal Meditech cannot provide safety documentation.
The recall does not specify a remedy, so check the product details to see if it matches the recalled items.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0042-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0042-2024 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.
