Recall issued for thousands of antigenic COVID-19 tests not approved by the FDA
Recall issued for thousands of antigenic COVID-19 tests not approved by the FDA

Recall issued for thousands of antigenic COVID-19 tests not approved by the FDA

TESTS ARE FOR LG.ON PEOPLE SET UP TO GET COVID TESTS AT HOME. STORES CANNOT KEEP THEM IN STOCK. MOST PEOPLE ARE DIFFERENT WITH FAST ANTIGENTES THAN THE GOLD STANDARD PCR TEST >> THEY ARE MUCH BETTER TO SET UP WHEN YOU ARE POTENTALLY INFECTED, THAT MEANS YOU HAVE MANY VIRUSES, ESPECIALLY IN YOUR UPPER. KIM: DR. PEKOSZ SAYS PCRES TTS ARE MORE SENSITIVE AND CAN BE ADOPTED ON SMALLER PARTICULARS OF VIRUSES. SO IF YOU TEST NEGATIVE ON A HOME TEST, IT IS NOT A GUARANTEE THAT YOU ARE NOT INFECTED, BUT YOU MAY NOT BE CONTAGIS.OU >> THERE MAY BE MLYEANS IN THE NEXT SIX HOURS, SEVEN IN HOURS, COULD HAVE A HIGH PROBABILITY TO SPREAD THE INFECTION KIM: SO HE SAYS IT’S GOOD TO USE BEFORE GOING TO AN EVENT OR FILAMI COLLECTION. AND IF YOU THINK YOU HAVE INFECTED ME, YOU CAN USE SEVERAL HURTESTS IN A SHORT TIME TO CONFIRM. EVERY TEST MARK IS DIFFERENT TO USE, SO GETTING ACCURATE RESULTS IS ABOUT TWO CRITICAL THINGS IN >> ONE IS TO GET THE SAMPLE IN THE RIGHT WAY, SO YOU MUST REALLY FOLLOW THE INSTRUCTIONS AND INSTRUCTIONS. FOLLOWING THE INSTRUCTIONS ON HOW TO GET THE SWAB. AND THEN THE CRITICAL THG INIS WAITS A LONG TIME TO, ON THE STTE RESULT REALLY READ TO THE LITTLE UNIT YOU GET WITH IT. KIM: AND IF YOU GET A POSITIVE RESULT ON A HOME TEST, IT’S A GOOD IDEA TO CONFIRM WITH AN RPC AND REPORT IT TO YOUR DOCTOR. >> ONE OF THE THINGS WE DON’T WANT ARE MANY PEOPLE WHO TEST POSITIVELY AT HOME AND DO NOT REPORT BACK TO THE PUBLIC HEALTH AUTHORITIES THAT THEY ARE INFECTED, BECAUSE WE DON’T GET ANYTHING, . SOME TIME. KIM: NOT ALL BRANDS OF HOME TESTS ARE CREATED EQL.UA WE HAVE PLACED A LINK THAT COMPARES SOME OF THEM ON OUR WEBSITE AND OUR MOBILE A

Recall issued for thousands of antigenic COVID-19 tests not approved by the FDA

Thousands of antigen COVID-19 tests have been revoked because they have not been approved, approved or approved by the US Food and Drug Administration. According to an FDA press release, 164,250 antigen and antibody tests from LuSys Laboratories are included in the recall. They were distributed between June 1, 2020 and July 21, 2021. The company’s antigen or antibody test can also be sold under the company’s other names, including Luscient Diagnostics, Vivera Pharmaceuticals or the trade name EagleDx. The tests were revoked because they did not receive FDA Emergency Use Authorization, which means they could not be legally marketed or distributed in the United States. the news release. “This means that there is a risk of potential false negatives, false positives and misinterpretation of results from these tests.” Anyone tested for COVID-19 using LuSys Laboratories antigen tests may be affected, along with healthcare providers and other organizations that used the tests. According to the FDA, LuSys Laboratories sent emergency medical device recall letters to customers and distributors immediately to stop using the tests and notify any third parties of the recall. The letters also instructed customers to discard, destroy and return all COVID-19 tests from LuSys Laboratories. Customers with questions can contact LuSys Laboratories at 858-733-2128 or email [email protected]

Thousands of antigen COVID-19 tests have been revoked because they have not been approved, approved or approved by the US Food and Drug Administration.

According to one news release from the FDA, 164,250 antigen and antibody tests from LuSys Laboratories are included in the recall. They were distributed between June 1, 2020 and July 21, 2021.

The company’s antigen or antibody test can also be sold under the company’s other names, including Luscient Diagnostics, Vivera Pharmaceuticals or the trade name EagleDx.

The tests are being revoked because they have not received an emergency use permit from the FDA, which means they cannot be legally marketed or distributed in the United States.

“Additionally, LuSys Laboratories did not provide appropriate validation data to demonstrate that the tests can be performed accurately,” the FDA news release said. “This means that there is a risk of potential false negatives, false positives and misinterpretation of results from these tests.”

Anyone tested for COVID-19 using antigen tests from LuSys Laboratories could be affected, along with healthcare providers and other organizations using the tests.

According to the FDA, LuSys Laboratories sent urgent letters about recall of medical devices to customers and distributors, asking them to immediately stop using the tests and notify any third parties of the recall. The letters also instructed customers to discard, destroy and return all COVID-19 tests from LuSys Laboratories.

Customers with questions can contact LuSys Laboratories at 858-733-2128 or email at [email protected].

Leave a Reply

Your email address will not be published.