ellume covid-19 home test recall

Ellume Home COVID Tests Recalled Because of False Positives- ellume covid-19 home test recall ,Nov 12, 2021·Nov. 12. 2021 -- Ellume is recalling about 2.2 million of its home coronavirus tests because of false positive test results, the FDA said in a news release.. The recall is an expansion of the ...Ellume recalls 2 million at-home COVID tests over false ...Nov 11, 2021·Ellume is recalling more than 2 million at-home COVID-19 test kits over concerns of high rates of false positives, the U.S. Food and Drug Administration announced Wednesday. A false positive is when the test tells people they have the virus when they in fact do not. The FDA says however that the test's reliability of negative test results has not been affected.



FDA recalls 2.2 million at-home coronavirus tests due to ...

Nov 11, 2021·WASHINGTON - The FDA announced this week that the recall of more than 2.2 million at-home COVID-19 tests by digital diagnostics firm Ellume is being classified as a class 1 recall, which is the most serious type due to the potential for "serious adverse health consequences or death.". Ellume's at-home test detects proteins from the SARS-CoV-2 virus …

Recall of Ellume at-home COVID antigen tests grows to more ...

Nov 12, 2021·Ellume initiated the recall of its COVID-19 Home Tests on Oct. 1, citing an unspecified manufacturing issue that made certain lots of the rapid antigen tests more susceptible to returning false ...

FDA recalls 2.2 million Ellume COVID-19 home tests due to ...

Nov 11, 2021·The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume due to "higher-than-acceptable false positive test results." Ellume, the first company...

More than 2 million Ellume at-home COVID-19 tests recalled

Nov 11, 2021·The FDA announced a recall of more than 2 million Ellume at-home COVID-19 tests due to “higher-than-acceptable false positive test results". The regulator has classified this recall as a Class I ...

Ellume Health At-Home COVID-19 Test Recalled – NBC 5 ...

The FDA issued an alert and Ellume Health, the makers of an at-home COVID-19 test, has issued a voluntary recall for tests sold at retailers beween April and August that may give a …

Class 1 Device Recall Ellume COVID19 Home Test

Oct 01, 2021·Recall Status 1: Open 3, Classified: Recall Number: Z-0183-2022: Recall Event ID: 88801: Product Classification: Coronavirus antigen detection test system. - Product Code QKP: Product: Ellume COVID-19 Home Test: Code Information

Class 1 Device Recall Ellume COVID19 Home Test

Oct 01, 2021·Recall Status 1: Open 3, Classified: Recall Number: Z-0183-2022: Recall Event ID: 88801: Product Classification: Coronavirus antigen detection test system. - Product Code QKP: Product: Ellume COVID-19 Home Test: Code Information

Australian Firm Recalls Over 2 Million US COVID Tests

Nov 10, 2021·FILE - Employees work on the production line of a COVID-19 coronavirus home test unit, at the production facility of Australian digital diagnostics company Ellume in …

Potential False Positive Results: Certain Ellume COVID-19 ...

Oct 06, 2021·Ellume said affected customers will be notified through the Ellume COVID-19 home test app. Within two weeks, the company will email consumers who tested positive with a recalled product, the...

Coronavirus Updates: Ellume at-home COVID tests recalled ...

Nov 11, 2021·NEW YORK (WABC) -- The FDA is elevating the seriousness of its recall for some at-home COVID-19 tests. Officials say 2.2 million Ellume tests are now being recalled because of the risk of false ...

Ellume's COVID-19 home test recall most serious, FDA says

Nov 10, 2021·The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker ...

Recall for home COVID tests: Ellume home COVID-19 tests ...

Dec 22, 2021·As of Dec. 16, the FDA lists this as the only active recall for COVID-19 home tests. Earlier this year, Ellume test kits were voluntarily recalled by the manufacturer because some batches were ...

Ellume's COVID-19 home test recall most serious, FDA says ...

Nov 10, 2021·The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker ...

Ellume's COVID-19 home test recall most serious, FDA says ...

Nov 10, 2021·The U.S. Food and Drug Administration classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker ...

Brisbane company Ellume recalls some COVID-19 at-home ...

Oct 06, 2021·CEO and founder Dr Sean Parsons said they were voluntarily recalling specific lots of the Ellume COVID-19 Home Test kits.(ABC News: Jessica Rendall)Ellume chief executive and founder Dr Sean ...

Recall for home COVID tests: Ellume home COVID-19 tests ...

Dec 22, 2021·As of Dec. 16, the FDA lists this as the only active recall for COVID-19 home tests. Earlier this year, Ellume test kits were voluntarily recalled by the manufacturer because some batches were ...

FDA recalling 2 million Ellume at-home COVID-19 test kits ...

Nov 11, 2021·The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume. The federal regulatory agency says ...

Ellume Recalls More Than 2 Million At-Home Covid-19 Tests ...

Nov 11, 2021·The Food and Drug Administration said more than 2 million at-home Covid-19 tests from Australia-based Ellume USA LLC have been recalled because of a number of false-positive results. The federal ...

At-home COVID-19 tests voluntarily recalled in North ...

Dec 23, 2021·The FDA has information on its website about the recall, saying Ellume is recalling certain lots over a "higher-than-acceptable" false-positive test result for COVID-19.

FDA Expands Recall of Ellume COVID-19 Home Tests

Nov 15, 2021·The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests made by the company that were ...

At-Home COVID-19 Antigen Test Kits: Where to Buy and What ...

Dec 21, 2021·Ellume has recalled certain lots of its COVID-19 Home Test because they may provide false-positive results. To determine whether an Ellume test you have is affected by the recall, visit the ...

Ellume Health At-Home COVID-19 Test Recalled – NBC 5 ...

The FDA issued an alert and Ellume Health, the makers of an at-home COVID-19 test, has issued a voluntary recall for tests sold at retailers beween April and August that may give a …

FDA Issues Class I Recall For Over 2 Million COVID-19 Home ...

Nov 11, 2021·The Food and Drug Administration announced it has issued a Class I recall for COVID-19 home test kits made by Ellume because of a high rate of false positives. The Class I recall, which is the most serious type of recall, affects over two million rapid antigen tests.

Ellume recalls 2 million at-home COVID tests over false ...

Nov 11, 2021·Ellume is recalling more than 2 million at-home COVID-19 test kits over concerns of high rates of false positives, the U.S. Food and Drug Administration announced Wednesday. A false positive is when the test tells people they have the virus when they in fact do not. The FDA says however that the test's reliability of negative test results has not been affected.

FDA Expands Recall of Ellume COVID-19 Home Tests

Nov 15, 2021·The Food and Drug Administration (FDA) has expanded its recall of Ellume at-home COVID-19 tests due to potential false-positive results. More than 2 million tests made by the company that were ...

What's the Most Accurate At-Home COVID Test?

Dec 06, 2021·Recall of Ellume Although it has been a popular choice, in October 2021, Ellume’s COVID-19 Home Test was recalled by the FDA because of too many false-positive results, indicating people had COVID-19 when they actually did not. The Ellume test is a rapid antigen test available without a prescription.