The Food and Drug Administration (FDA) of United States has posted a medical device safety alert concerning the tests manufactured by Universal Meditech, Inc. (UMI):
- One Step Pregnancy Test
- One Step Ovulation Test
- DiagnosUS One Step LH Ovulation Test (Strip)
- DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test
- DiagnosUS One Step FSH Menopausal Test (Strip)
- DiagnosUS hCG Pregnancy Urine Test Strip Format
- DiagnosUS hCG Pregnancy Urine Test Cassette Format
- DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format
- DiagnosUS Pregnancy Test Midstream
- DiagnosUS Ovulation Predictor Midstream
- 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
- hCG Pregnancy Cassette
- Am I Pregnant Pregnancy Midstream Test
- hCG Pregnancy Strips
- PrestiBio Pregnancy Strips
- PrestiBio Rapid Detection Pregnancy Test Midstream
- PrestiBio Ovulation Strips
- PrestiBio Ovulation and Pregnancy Strips
- PrestiBio Urinalysis Test Strip
- PrestiBio Ketone Test Strips
- PrestiBio Breast Milk Alcohol Test Strips
- Lem Fertility hCG Pregnancy Urine Test
- Lem Fertility LH Ovulation Test (Strip)
According to the FDA, the manufacturer has stopped all operations and would not be able to continue fulfilling any post-market responsibilities of these distributed products. The FDA is not able to confirm the performance of UMI’s tests, raising concerns that the tests may not be safe and effective.
For further information, please visit https://www.fda.gov/medical-devices/safety-communications/do-not-use-tests-manufactured-universal-meditech-inc-fda-safety-communication
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-all-products-manufactured-between-march-2021-and
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-expands-nationwide-recall-all-products-manufactured-between-march-2021-and
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Aug 2023
Updated on 25 Sep 2023