Universal Meditech Inc. is recalling approximately 536,385 diagnostic test kits across several brands, including PrestiBio, HealthyWiser, DiagnosUS, and Lem Fertility. These products, which range from pregnancy and ovulation tests to COVID-19 antibody and urinalysis strips, were distributed without proper FDA marketing authorization. Because the company is going out of business, they can no longer ensure the safety, quality, or effectiveness of these medical devices.
The performance of these tests is unknown because the manufacturer cannot provide documentation that they meet quality standards or were stored at correct temperatures. Using these devices could lead to incorrect test results, which may delay proper medical treatment or lead to inappropriate health decisions.
Discontinue use of diagnostic tests
One Step® Pregnancy Test
One Step® Ovulation Test
HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis
HealthyWiser UriTest™ UTI Test Strips:
HealthyWiser KetoFast™ Ketone Test Strips
HealthyWiser pH-Aware™ pH Test Strips
hCG Pregnancy Cassette & hCG Pregnancy Strips
Am I Pregnant Pregnancy Midstream Test
PrestiBio™ Breastmilk Alcohol Test Strip
PrestiBio™ Ovulation Strips (Outer Packaging Box)
PrestiBio™ Ovulation Strips (Inner Foil Pouch):
PrestiBio™ Ovulation and Pregnancy Strips:
PrestiBio™ Pregnancy Strips (Outer Packaging Box):
PrestiBio™ Pregnancy Strips (Outer Packaging Box):
PrestiBio™ Rapid Detection Pregnancy Test Midstream:
PrestiBio™ Ketone Test Strips:
PrestiBio™ Urinalysis Test Strip:
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · FDA Press Release (3) · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.