Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is warning consumers and patients to not use the following tests manufactured by Universal Meditech, Inc. (UMI): 

• 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 notified the FDA that it has stopped all operations and is no longer providing support for its tests. The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective. 

Tests have been sold online to consumers by at least four distributors:

• AC&C Distribution, LLC.
• HealthyWiser
• Home Health US Inc.
• Prestige Biotech Inc.

These tests were distributed under the brand names of those distributors, and tests may not have identified UMI as the manufacturer. These tests may also have been distributed by other distributors.

While UMI initiated a recall to remove undistributed tests from their distributors, UMI did not initiate a recall for tests that were already distributed to consumers. Given FDA’s 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. 

Recommendations for Consumers and Patients

• Do not use or purchase the tests listed above.
• Immediately stop using and destroy these recalled tests by placing them in the trash.
• If you used one of the recalled tests and still want results from such a test, test again using a different test and consider discussing with a health care provider if you have concerns about the accuracy of your test results.
• Report any adverse events or quality problems experienced with the use of these tests to the FDA's MedWatch Adverse Event Reporting program.

FDA Actions

The FDA will continue to monitor this situation. The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device or test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. 

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

Read the full alert.