August 14, 2023 – The U.S. Food and Drug Administration is warning patients against using certain tests made by Universal Meditech Inc. (UMI), including tests for pregnancy, ovulation and urinary tract infections.
“UMI has notified the FDA that it has ceased all activities and is no longer providing support for its testing,” the The FDA said“The FDA cannot confirm the performance of UMI's tests, which raises concerns that the tests may not be safe and effective.”
The company recalled unsold tests from distributors, but not tests sold to consumers, the FDA said.
The FDA stated that customers mustn’t use these tests:
- One-step pregnancy test
- DiagnosUS One-Step Ovulation Test
- HealthyWiser UriTest 10 parameter reagent test strips for urine evaluation
- HealthyWiser UriTest UTI Test Strips
- HealthyWiser KetoFast Ketone Test Strips
- HealthyWiser pH-Aware pH Test Strips
- To Life hCG Pregnancy Urine Test
- Am I pregnant? Pregnancy Midstream Test
- DeTec hCG pregnancy urine test
- PrestiBio stretch marks
- PrestiBio Pregnancy Rapid Test Midstream
- PrestiBio ovulation strips
- PrestiBio Urinalysis Test Strips 10 Parameters
- PrestiBio Ketone Test Strips
- PrestiBio Breast Milk Alcohol Test Strips
At least 4 wholesalers have sold tests online – AC&C Distribution LLC, HealthyWiser, Home Health US Inc. and Prestige Biotech Inc. The FDA said tests distributed by these corporations is probably not identifiable as having been manufactured by UMI.
The FDA said anyone who bought one in every of these tests should throw it away.
“If you used one of the recalled tests and still want results from that test, repeat the test using a different test,” the FDA said.