Universal Meditech recalls To Life hCG Pregnancy Urine Test Strips due to unverified safety and regulatory compliance. The recall follows the company's closure and inability to provide documentation for product safety.
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 To Life hCG Pregnancy Urine Test Strips because the company is closing and cannot provide safety documentation. This recall affects products sold under the model number 100-13 with lot numbers hCG-S-2210-03.
The recall is due to Universal Meditech's closure and inability to provide documentation proving the test strips meet safety and regulatory standards. The company claims to hold 510(k) approvals but FDA has not verified this information, raising concerns about product safety.
Pregnant individuals who purchased the To Life hCG Pregnancy Urine Test Strips from Universal Meditech are affected. Those who used the test strips without verifying the manufacturer's compliance could be at risk.
Check for the model number 100-13 and lot number hCG-S-2210-03 on the test strips. The product does not have a UDI-DI code.
Look for the model number 100-13 and lot number hCG-S-2210-03 on the test strips.
Universal Meditech is recalling the test strips because they are closing and cannot provide safety documentation. FDA has not verified the company's claims about regulatory compliance.
Check the model number and lot number on the test strips. If you have the specific model and lot number, contact Universal Meditech for guidance.
The recall is due to unverified safety documentation, but the specific risk of injury is not clearly stated in the official notice.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0050-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0050-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
