Throw Away These Illegally Produced Home Pregnancy Tests, Says FDA
Following an arrest in an illegal medical lab in California involving a dozen government agencies, the Food and Drug Administration is warning consumers against using Universal Meditech, Inc. ‘s home pregnancy tests. (UMI) that have been distributed under several names and are sold on several online platforms
Pregnancy tests are not accurate, according to the FDA, and anyone who has used one should consider the results suspicious.
How to know if you bought one of the illegal pregnancy tests
In addition to pregnancy tests, UMI’s recalled products include strip-based tests used to detect ovulation, ketones, and alcohol in breast milk. The products have been marketed under various names, including:
- One step pregnancy test
- DiagnosUS One Step Ovulation Test
- Reagent test strips HealthyWiser UriTest for 10 parameters for urinalysis
- HealthyWiser UriTest UTI Test Strips
- HealthyWiser KetoFast Ketone Test Strips
- HealthyWiser pH-Aware pH Test Strips
- Urinalysis for hCG pregnancy To Life
- I am pregnant? Average pregnancy test
- Urinalysis for pregnant women for hCG DeTec
- PrestiBio pregnancy strips
- PrestiBio Rapid Detection Midstream Pregnancy Test
- PrestiBio Ovulation Strips
- PrestiBio urinalysis test strips, 10 parameters
- PrestiBio Ketone Test Strips
- PrestiBio test strips for alcohol content in breast milk
The tests were sold over the Internet by several distributors, including AC&C Distribution, LLC; HealthyWiser; Home Health USA Inc.; and Prestige Biotech Inc. The products sold by these distributors did not always use the UMI name as part of the brand name. According to the FDA, it is also possible that the products were sold by other distributors.
UMI has recalled unsold tests from its distributors, but has not recalled tests that have already been sold to the public. The FDA issued a safety advisory to warn the public of the risks associated with illegal test production.
What to do if you have used one of the pregnancy tests or UMI test strips
If you see them for sale, do not buy any of the UMI products listed above. If you already have pregnancy tests or test strips at home, the FDA recommends that you throw them away. If you have already used it, the FDA recommends testing again using a different non-UMI test. If you have concerns about the accuracy of results from a test you have already used, check with your doctor.
If you experience any unusual events or notice problems with previously used tests, you can report them to the FDA’s MedWatch Adverse Event Reporting Program . If you have questions, you can also email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.