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

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):

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:

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.

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

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.

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.

08/11/2023