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

Update: October 18, 2023

The FDA is adding to the list of recalled tests manufactured by Universal Meditech, Inc. (UMI), and distributors identified in the recall, based on new information provided by UMI. The updated lists of tests and distributors are below.

The FDA recommendations below have not changed.

Date Issued: August 11, 2023

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
DiagnosUS One Step LH Ovulation Test (Strip) (added Oct. 18, 2023)
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test (added Oct. 18, 2023)
DiagnosUS One Step FSH Menopausal Test (Strip) (added Oct. 18, 2023)
Lem Fertility hCG Pregnancy Urine Test (added Oct. 18, 2023)
Lem Fertility LH Ovulation Test (Strip) (added Oct. 18, 2023)
DiagnosUS hCG Pregnancy Urine Test Strip Format (added Oct. 18, 2023)
DiagnosUS hCG Pregnancy Urine Test Cassette Format (added Oct. 18, 2023)
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format (added Oct. 18, 2023)
DiagnosUS Pregnancy Test Midstream (added Oct. 18, 2023)
DiagnosUS Ovulation Predictor Midstream (added Oct. 18, 2023)

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 to distributors and customers, including online to consumers, and recalled tests may have been further distributed by some of all of the following firms:

AC&C Distribution, LLC.
HealthyWiser
Home Health US Inc.
Prestige Biotech Inc.
American Screening Corp. (added Oct. 18, 2023)
Emergency Diagnostic Solutions (added Oct. 18, 2023)
International Diagnostic Equipment (added Oct. 18, 2023)
LEM Fertility (added Oct. 18, 2023)
Medgyn Products (added Oct. 18, 2023)
Perez Distributing (added Oct. 18, 2023)
RGH Enterprises Inc. (added Oct. 18, 2023)

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.

One Step Pregnancy Test 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	To detect pregnancy.
DiagnosUS One Step Ovulation Test PrestiBio Ovulation Strips	To detect ovulation.
HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis PrestiBio Urinalysis Test Strip 10 Parameters	To detect glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes.
HealthyWiser UriTest UTI Test Strips	To detect nitrite and leukocytes as an aid in the diagnosis of urinary tract infection (UTI).
HealthyWiser KetoFast Ketone Test Strips PrestiBio Ketone Test Strips	To detect ketone.
HealthyWiser pH-Aware pH Test Strips	To detect pH.
PrestiBio Breast Milk Alcohol Test Strips	To detect alcohol in breast milk.

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 DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.