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Ellume Covid-19 Home Test Recall – False Positive Results Lead To Class 1 Recall

Ellume COVID-19 Home Test Recall Over Potential False Positive Results

The US Food and Drug Administration (FDA) is recalling more than 2.2 million at-home covid-19 tests manufactured by Australian company Ellume in a Class 1 recall — the agency’s most serious kind of recall.

False Positive Test Results Impact

On November 11, the FDA announced a recall of 2,212,335 lots of the Ellume COVID-19 Home Test made between February 24 and August 11, 2021.

According to the recall, the test kits are being recalled due to a higher-than-acceptable rate of false-positive results for COVID-19. Meanwhile, negative tests retain their reliability.

However, the FDA notes that false positives can sometimes be life-threatening.

The Food and Drug Administration classified this as a Class 1 recall, the most serious kind of recall. These tests have the potential to result in major adverse health outcomes or death.

If a test indicates that a person has the virus when they do not, the FDA advises that it may create a delay in recognizing the actual cause of the individual’s condition, which could be another life-threatening disease.

It can potentially expose those who do not have COVID-19 to the virus if they are quarantined alongside those who do. Additionally, serious side effects may occur when COVID-19 treatments are delivered to someone who does not have the virus.

Meanwhile, those who think they have already got the virus may postpone vaccination, resulting in an additional spread of COVID-19. Some consumers who received a false positive result may have also missed work or school due to the issue.

The FDA stated that the company notified it of the faulty testing in October. The FDA has received 35 false positive reports from these tests. There have been no reported fatalities.

About the Recalled Product

The over-the-counter nasal swab tests are available at pharmacies and grocery stores and can be performed at home. Retailers selling the tests have been told to remove affected products and immediately stop sales, quarantine the products, and contact an Ellume sales representative for further instructions about the Ellume Covid-19 Home Test Recall.

Customers can locate product lot numbers on the Ellume COVID-19 Home Test carton’s sticker on the side. Match the lot number with the list of recalled lots. Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H.

Lastly, consumers who have not yet used the affected tests will have them disabled via a software update. Additionally, Ellume will inform consumers who used an affected test and had a positive result.

Editor’s Note on Ellume Covid-19 Home Test Recall :

This article is written to inform you of the latest recall of Ellume COVID-19 Home Test due to the potential false positive results.

Case Name & No.: Ellume COVID-19 Home Test Recall

Jurisdiction: USA

Reason: Potential False Positive COVID-19 test results

Have you used Ellume COVID-19 Home Test and got a “positive” result? Click the “Contact Us” button below and share with us your thoughts!

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