Universal Meditech recalls PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS due to unverified safety and lack of post-market support. 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 PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS because they were distributed without proper FDA approval and the company is going out of business. This means the tests may not be safe or effective as intended.
The tests were distributed without FDA marketing authorization and the manufacturer is going out of business. This means they cannot provide post-market support, documentation of safety, or quality control checks, which could lead to inaccurate results or potential health risks.
Pregnant individuals who purchased the PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS after March 2021 are affected. Those who rely on these tests for pregnancy detection without proper verification are at higher risk.
Check for the model number 100-17 on the test kit. Products manufactured after March 2021 are affected. The UDI-DI code is listed as None.
Verify the model number and production date on the test kit to confirm if it is affected.
Universal Meditech distributed these tests without FDA marketing authorization and is going out of business, so they cannot provide post-market support or safety documentation.
The recall is due to unverified safety and lack of post-market support, but specific risks like inaccurate results or health issues are not clearly stated.
Look for the model number 100-17 and check that it was manufactured after March 2021.
We’ve drafted a message you can send Universal Meditech to request your refund or repair — edit it as you like.
Subject: Recall Z-0055-2024 — Universal Meditech Universal Meditech Hello, I own a Universal Meditech that is covered by recall Z-0055-2024 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.
