FDA Warns Consumers: Do Not Use Universal Meditech Tests for Pregnancy and Urinary Tract Infections
The US Food and Drug Administration (FDA) has issued a warning to consumers regarding certain tests manufactured by Universal Meditech Inc. The FDA advises against the use of these tests for pregnancy, ovulation, and urinary tract infections, as there are concerns about their safety and effectiveness.
Universal Meditech Inc., based in California, has informed the FDA that it has ceased all operations and is no longer providing support for its tests. This inability to verify the performance of Universal Meditech’s tests raises serious concerns about their reliability.
While the company has recalled undistributed tests, there has been no recall for tests that have already been distributed to consumers. As a precautionary measure, consumers are strongly advised not to purchase or use Universal Meditech tests and should discard them immediately.
The affected Universal Meditech tests include:
– 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 Urinalysis Test Strip 10 Parameters
– PrestiBio Breast Milk Alcohol Test Strips
These tests may have been distributed under different brand names, including AC&C, HealthyWiser, Home Health US, and Prestige Biotech.
If individuals have already used any of these tests and still desire accurate results, they are advised to test again using a different brand. If concerns about accuracy persist, it is recommended to consult a healthcare provider.
Consumers are urged to report any issues or problems related to these tests to the FDA through its MedWatch program.
In summary, the FDA is cautioning consumers against using Universal Meditech tests for pregnancy, ovulation, and urinary tract infections due to concerns over their safety and effectiveness. The manufacturer has notified the FDA of the termination of its operations and lack of support for its tests. Consumers should refrain from purchasing or using these tests and dispose of them properly. If accurate results are still needed, it is advisable to test using an alternative brand and consult a healthcare professional if there are concerns about accuracy. Reporting any problems with these tests to the FDA is encouraged.
