Do not use certain pregnancy, ovulation, UTI tests, FDA warns

UPDATING THE LIST OF VACCINES THAT PREGNANT WOMEN CAN GET TO PROTECT THEMSELVES AND THEIR BABIES. HERE TO EXPLAIN IS DOCTOR SIMONE WILDES, AN INFECTIOUS DISEASE SPECIALIST AT SOUTH SHORE HEALTH. HI, DR. WILDE. HEY, DR. WILDE, IT’S ALWAYS GREAT TO SEE YOU. SO, AS YOU KNOW, THE FDA IS CURRENTLY REVIEWING THE SAFETY AND THE EFFICACY OF A NEW VACCINE FOR PREGNANT WOMEN THAT’S DESIGNED TO PROTECT THEIR BABIES FROM RSV AFTER THEY’RE BORN. HOW DO WE KNOW THAT THE STRATEGY WORKS? AND IT’S REALLY AN IMPORTANT QUESTION. WHAT WE DO KNOW THAT WE HAVE HISTORY FROM VACCINES SUCH AS FLU, COVID, AND THEY HAVE SHOWN THAT, YOU KNOW, VACCINES GIVEN DURING PREGNANCY ARE VERY EFFECTIVE IN PROTECTING OUR BABIES. NOW, THEY HAVE SHOWN THAT WITH RSV, IT HAS BEEN EFFECTIVE. IN FACT, ABOUT 82% EFFECTIVE IN PREVENTING SEVERE RSV IN OUR BABIES. SO THIS STRATEGY WORKS. AND SO IT’S IMPORTANT THAT WE CONTINUE USING THIS. WELL, WE KNOW FULL TERM PREGNANCY LASTS 40 WEEKS. SO YOUR OPINION, WHAT IS THE BEST TIME TO SCHEDULE THOSE SHOTS FIRST, SECOND, THIRD TRIMESTER? SHAYNA? HAYNA, REALLY IMPORTANT TIMING IS VERY IMPORTANT WITH REGARDS TO WHEN WE GIVE VACCINES. SO WHAT WE HAVE SHOWN IS THAT WITH COVID AND WITH FLU, YOU CAN GIVE THE VACCINE AT ANY TIME. HOWEVER, WITH RSV, THE STUDIES NOW SHOW THAT THEY GIVE IT LATER, 24 TO 36 WEEKS SEEMS TO BE THE TIME IN WHICH THIS VACCINE SHOULD BE GIVEN THE REALLY IMPORTANT THING. TALK WITH YOUR HEALTH CARE PROVIDER AS TO WHEN YOU SHOULD GET THE VACCINE. AND I’M CURIOUS, DR. WELLS, THE CDC SAYS THAT THERE ARE CERTAIN VACCINES THAT PREGNANT WOMEN SHOULD NOT GET AGAIN, SHOULD NOT GET SO. SO WHAT’S ON THAT LIST? YEAH, REALLY IMPORTANT. ADD SOME VACCINES. WE DO NOT GIVE TO PREGNANT WOMEN. THE REASON IS IT’S HARMFUL TO THE BABY ON THE LIST. I’LL GIVE YOU A FEW. IT’S HUMAN PAPILLOMAVIRUS VACCINE OR HPV. THERE’S MEASLES, MUMPS AND RUBELLA VACCINE. THERE’S A LIVE FLU VACCINE AND ALSO CHICKEN POX THAT ONE WE DON’T GIVE. AND OF COURSE, THERE’S ALSO SOME TRAVEL VACCINES. AGAIN, AGAIN, MY TAKE HOME SPEAK TO YOUR PROVIDER TO MAKE SURE YOU ARE GETTING THOSE VACCINES. GREAT ADVICE. AL

Consumers shouldn't use certain tests manufactured by Universal Meditech Inc., the U.S. Food and Drug Administration warned Friday, including those that test for pregnancy, ovulation and urinary tract infections."UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests," the agency said. "The FDA is not able to confirm the performance of UMI's tests, raising concerns that the tests may not be safe and effective."The California-based company has recalled undistributed tests but not those that have already been distributed to consumers.Consumers are advised not to purchase or use the following Universal Meditech tests but rather to throw them away:One Step Pregnancy TestDiagnosUS One Step Ovulation TestHealthyWiser UriTest 10 Parameter Reagent Test Strips for UrinalysisHealthyWiser UriTest UTI Test StripsHealthyWiser KetoFast Ketone Test StripsHealthyWiser pH-Aware pH Test StripsTo Life hCG Pregnancy Urine TestAm I Pregnant Pregnancy Midstream TestDeTec hCG Pregnancy Urine TestPrestiBio Pregnancy StripsPrestiBio Rapid Detection Pregnancy Test MidstreamPrestiBio Ovulation StripsPrestiBio Urinalysis Test Strip 10 ParametersPrestiBio Ketone Test StripsPrestiBio Breast Milk Alcohol Test StripsThe tests may have been distributed under brand names such as AC&C, HealthyWiser, Home Health US and Prestige Biotech.Anyone who has used one of these tests and still wants results should test again with a different brand and reach out to a health care provider if they have concerns about accuracy.Consumers may report problems with devices or tests to the FDA through its MedWatch program.

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

The California-based company has recalled undistributed tests but not those that have already been distributed to consumers.

Consumers are advised not to purchase or use the following Universal Meditech tests but rather to throw them away:

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

The tests may have been distributed under brand names such as AC&C, HealthyWiser, Home Health US and Prestige Biotech.

Anyone who has used one of these tests and still wants results should test again with a different brand and reach out to a health care provider if they have concerns about accuracy.

Consumers may report problems with devices or tests to the FDA through its MedWatch program.

Do not use certain pregnancy, ovulation, UTI tests, FDA warns

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