Pregnancy Test Safety Communication

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

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 has warned consumers and patients not to use these tests - https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication

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.

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