<p class="p1">The Australian medical technology company Ellume has recalled over 2 million of its at-home COVID-19 tests over potential false positives.</p>
<p>The recall, defined by the FDA as Class I, is &#8220;the most serious&#8221; of the types of recalls. &#8220;Use of these tests may cause serious adverse health consequences or death,&#8221; the FDA notes.</p>
<p class="p1">The test, according to the FDA, “detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.” It “is available without a prescription for use by people with or without COVID-19 symptoms” and “uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.”</p>
<p>A spokesperson for Ellume told The New York Times the root cause of the problem has been identified.</p>
<p class="p1">“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” said a spokesperson. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”</p>
<p class="p1">As <a href="https://www.npr.org/2021/11/11/1054606822/fda-recalling-2-million-ellume-at-home-covid-19-test-kits-because-of-false-posit"><span class="s1">reported</span></a> by NPR, “The company first informed the FDA about the defect in some lots in October. On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect.”</p>
<p class="p1">Last month, Dr. Sean Parsons, the company’s chief executive, <a href="https://www.nytimes.com/2021/11/10/health/home-covid-test-kits.html"><span class="s1">said</span></a> that the company had created more measures to stop the problem from happening again.</p>
<p class="p1">“I’m very sorry that this has happened,” he said. “We’re all about chasing accuracy, and to have these false positives is disappointing.”</p>
<p class="p1">The FDA described the reason for the recall, stating:</p>
<blockquote>
<p class="p1"><i>Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected. For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:</i></p>
</blockquote>
<ul>
<li><i>Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.</i></li>
<li><i>Further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.</i></li>
<li><i>The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.</i></li>
<li><i>Disregard for the recommended precautions against COVID-19, including vaccination.</i></li>
<li><i>Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.</i></li>
</ul>
<p class="p1">There have reportedly been 35 cases reported where the devices showed a false positive, but it is unknown how many false positives the defective devices actually demonstrated.<span class="Apple-converted-space"> </span></p>
<p class="p1">As <a href="https://www.cnn.com/2021/11/11/health/ellume-covid-test-recall/index.html"><span class="s1">reported</span></a> by CNN, “In February, the Biden administration announced a <span class="s2">$231.8 million award</span> for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make <span class="s2">more tests available</span>.&#8221;</p>
<p class="p1">

<script async src="https://www.instagram.com/embed.js"></script>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
<script async src="https://www.tiktok.com/embed.js"></script><div data-widget-host="revcontent" data-pub-id="165152" data-widget-id="290588"></div><script src="https://delivery.revcontent.com/165152/290588/widget.js"></script>

Over 2 Million At-Home COVID Tests Recalled Over False Positives

CONTINUE READING

The Unanswered Question At The Center Of The SCOTUS Idaho Abortion Decision

How The Pro-Life Movement Can Positively Influence Laws Surrounding Fertility Treatments

Why Supporting Pregnant Incarcerated Women Is a Pro-Life Stand

Why Children Need Parents To Put The Phone Down And Look Them In The Eye

Postpartum Depression And The Devaluation Of Motherhood 

Why Gen Z Is Turning To Dating Apps To Find Friends, Fight Loneliness

News and Commentary

COVID

A video goes viral showing a baby being refused his mother by two gay "dads". This is just the tip of the iceberg, which is why we will have an important discussion today about surrogacy. 

Hour 1

The Matt Walsh Show

Ep. 1765 - This Video Is One Of The Worst Things I've Seen In A Long Time 

The Strait of Hormuz officially opens for business (kind of), the Pope makes “shocking” comments on immigration, and President Trump promises UFO disclosure at TPUSA. 


The Michael Knowles Show

Ep. 1956 -  Pope Leo's "SHOCKING" Immigration Comments EXPLAINED

A false miscreed has corrupted our leadership class.


The Andrew Klavan Show

Ep. 1275 - Dumb, Dumber and Progressive

President Trump announces a 10-day ceasefire between Lebanon and Israel, a murder-suicide involving former Democratic Lieutenant Governor Justin Fairfax shakes Virginia, and France and Britain hold a conference to secure the Strait of Hormuz – after the Iranian conflict ends. Get the facts first with Morning Wire.

- - -

Ep. 2738

- - -

Wake up with new Morning Wire merch: https://bit.ly/4lIubt3

- - -

Today's Sponsors:

Alliance Defending Freedom - Visit https://JoinADF.com/WIRE or text 'WIRE' to 83848 to learn more.

Pocket Hose - Text MORNING to 64000 to get a FREE pocket pivot and their 10-pattern sprayer with the purchase of ANY size Copper Head hose. Message and data rates may apply.

Morning Wire

U.S. Expands Hormuz Blockade & VA Fairfax Deaths Investigated | 4.17.26

U.S. Expands Hormuz Blockade & VA Fairfax Deaths Investigated | 4.17.26 [Member Exclusive]

A ceasefire goes into effect between Israel and Lebanon, a tragic murder-suicide rocks Virginia, and Dairy Queen deploys AI in the drive-thru. Get the facts first with Evening Wire.
- - -
Ep. 2737
- - -
Wake up with new Morning Wire merch: https://bit.ly/4lIubt3 
- - -
Today’s Sponsor:

Alliance Defending Freedom - Visit https://JoinADF.com/WIRE or text “WIRE” to 83848 to learn more.


Menu

— News and Commentary —

Over 2 Million At-Home COVID Tests Recalled Over False Positives