Nearly 200,000 COVID Tests Recalled After Kits Produced Huge Number of False Positives

Over the previous 12 months and a half, many individuals world wide have skilled the nerves and annoyance that include getting a constructive COVID-19 check outcome.

With a purpose to make the method extra handy, some have opted to take an at-home speedy check to keep away from the additional problem of ready at their native well being clinic.

But one model of those assessments doubtlessly misled hundreds of individuals.

About 195,000 at-home speedy COVID-19 check kits are being recalled by the Australian know-how firm Ellume for his or her excessive proportion of false-positive outcomes, ABC News reported Wednesday.

Out of the 202,000 kits which were utilized by shoppers, there have been 42,000 constructive outcomes, the outlet reported.


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A few quarter of these constructive assessments — greater than 10,000 — are presumed to be false, based on ABC Information.

Folks probably known as out sick for work, faculty and different commitments for a number of days to quarantine due to a faulty product.

Have you ever ever obtained a false-positive check outcome?

Ellume CEO Sean Parsons launched a statement concerning the voluntary recall during which he admitted his firm’s error.

“At Ellume, we perceive that belief is central to fulfilling our objective as an organization, and we acknowledge that this incident might have shaken the arrogance of a few of those that trusted Ellume to assist them handle their well being and to take again a little bit of management of their lives throughout this pandemic,” Parsons mentioned.

“To these people, I supply my honest apologies — and the apologies of our whole firm — for any stress or difficulties they might have skilled due to a false constructive outcome,” he mentioned.

Parsons mentioned his firm is engaged on improving the test kits as a way to stop the difficulty from occurring in future tons.

“You’ve got my private dedication that we now have discovered from this expertise, we now have carried out extra controls to make sure our product meets our top quality requirements and we’re going to do all the things in our energy to regain your belief,” he mentioned.


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“At Ellume, we stay completely dedicated to creating high-quality digital diagnostics that may be relied on in a well being disaster,” Parsons mentioned. “Affected person well-being and product high quality are our first priorities all through each step of the manufacturing and provide chain course of. We perceive you might be relying on us to do nothing much less.”

The corporate mentioned it had not run into a problem of false negatives, that means that this error would solely ship individuals into isolation with out motive.

About 427,000 of those kits, recalled and never, have been distributed to the general public retailers and the Department of Defense, based on ABC Information.

This recall ought to encourage individuals to get a second check if the primary one is constructive, particularly with this type of speedy testing, and particularly if their signs are nonexistent or minimal.

Ellume was right to be clear with the general public about the issue and recall its product. | Practically 200,000 COVID Checks Recalled After Kits Produced Big Variety of False Positives

Huynh Nguyen

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