The Food and Drug Administration has issued a “do not use” warning for various tests made by Universal Meditech, Inc.
The FDA said consumers and patients should avoid using the following tests:
- 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.
UMI has told the FDA that it has ceased operations and will not support the tests. The FDA said it cannot confirm the tests’ performance which raises concerns that they may not be safe or reliable.
They were sold online by several companies under the labels:
- AC&C Distribution, LLC.
- HealthyWiser.
- Home Health US Inc.
- Prestige Biotech Inc.
They may not be marked as UMI and may have been distributed by other companies.
UMI had already recalled tests from distributors, but the recall wasn’t pushed down to consumers, the FDA said. The federal agency said that given its “concerns about these tests, the FDA is issuing this safety communication to consumers and patients as part of its mandate to protect the public health.”
The FDA said that consumers should not purchase the recalled tests. If you have them, you’re told not to use them and to dispose of them in the trash. If you did use one, test again using a different kit and talk to your doctor if you have concerns over the results.
If you have questions, you can contact the FDA’s Division of Industry and Consumer Education at 800-638-2041 or via email.
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