FDA recalls several pregnancy, UTI tests after deeming them unsafe
INDIANAPOLIS (WISH) — The Food and Drug Administration has issued a warning for several products that test for pregnancy, UTIs, and other conditions because the tests have been deemed unsafe.
The manufacturer of the tests, Universal Meditech Limited, has stopped all operations and is no longer providing support for said tests. The FDA says it was not able to confirm the performance of the company’s tests, raising concerns that they were unsafe or ineffective.
The following is a list of products that have been recalled.
- One Step Pregnancy Test
- DiagnosUS 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
- To Life hCG Pregnancy Urine Test
- Am I Pregnant Pregnancy Midstream Test
- DeTec hCG Pregnancy Urine Test
- PrestiBio Pregnancy Strips
- PrestiBio Rapid Detection Pregnancy Test Midstream
- PrestiBio Ovulation Strips
- PrestiBio Urinalysis Test Strip 10 Parameters
- PrestiBio Ketone Test Strips
- PrestiBio Breast Milk Alcohol Test Strips
These tests have been sold online to the public under the brand names of at least four distributors.
- AC&C Distribution, LLC.
- Home Health US Inc.
- Prestige Biotech Inc.
The FDA says to not use or buy the tests listed above, and to immediately stop using and throw away the recalled tests. They also say to report any adverse effects or quality problems with the tests to the organization’s MedWatch Adverse Event Reporting program.
Universal Meditech Unlimited has not said why they have stopped production.