In the wake of a bust on an illegal medical lab in California involving a dozen government agencies, the Food and Drug Administration is warning consumers not to use at-home pregnancy tests made by Universal Meditech, Inc. (UMI), which were distributed under multiple names and sold on multiple online platforms
The pregnancy tests are not confirmed to deliver accurate results, per FDA, and anyone who has used one of them should consider the results suspect.
How to know if you bought one of the illegal pregnancy tests
In addition to pregnancy tests, the recalled products from UMI include strip-based tests used to detect ovulation, ketones, and alcohol in breast milk. The products were sold under a variety of names, including:
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 StripsPrestiBio Rapid Detection Pregnancy Test MidstreamPrestiBio Ovulation StripsPrestiBio Urinalysis Test Strip 10 ParametersPrestiBio Ketone Test StripsPrestiBio Breast Milk Alcohol Test StripsThe tests were sold online by multiple distributors, including AC&C Distribution, LLC; HealthyWiser; Home Health US Inc.; and Prestige Biotech Inc. Products sold by these distributors did not always use UMI’s name as the part of the brand name.It’s also possible the products were sold by other distributors, according to the FDA.
UMI has recalled unsold tests from their distributors but has not issued a recall for the tests that were already sold to the public. The FDA has issued its safety communication message in order to alert the public about the risks posed by the illegally manufactured tests.
What to do if you used one of UMI’s pregnancy tests or test strips
If you see them for sale, don’t buy any of the UMI products listed above. If you already have pregnancy tests or test strips at home, the FDA advises they should be thrown away. If you already used one, the FDA advises testing again using a different, non-UMI test. If you have concerns about the accuracy of the results you received on a test you already used, consult your doctor.
If you have experience any unusual events or observe 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.
