> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Warning on 15 Universal Meditech Tests
- URL: https://www.fdaweb.com/fda-warning-on-15-universal-meditech-tests/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:50:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155082

FDA has issued a warning to not use 15 tests manufactured by Reno, CA-based Universal Meditech after the company notified the agency that it has stopped all operations and is no longer providing support for its tests. An [FDA notice ](https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery)says it is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe or effective. Affected tests are:

- 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