Two million COVID-19 at-home test kits recalled over false positive results

[left-of-center2012]

Source: PennLive

A recall of at-home COVID-19 test kits that have the potential to produce false-positive results has been expanded to include 2 million kits. The Ellume brand of test kits were manufactured between Feb. 24 and Aug. 11 and distributed from April 13 to Aug. 26.

The U.S. Food and Drug Administration said 2,212,335 kits were distributed in the United States.

The kits are recalled “because they have higher-than-acceptable false-positive test results” meaning the test will indicate someone has COVID-19 when they do not. The positive results were seen “at a rate higher than researchers saw during clinical testing.” Ellume said it has removed all affected kits from the market and has notified customers.

The reliability of the negative test results are not affected.

Read more: https://www.pennlive.com/nation-world/2021/11/two-million-covid-19-at-home-test-kits-recalled-over-false-positive-results.html

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“We offer our sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” Ellume said

[SergeStorms]

1. So, of the 2,212,335 kits distributed....

only 2,000,000 are being recalled?

Might as well recall every freaking kit they ever made, right?

As if there's not enough stress in people's lives already.

[StarryNite]

2. Yikes

They need to get this stuff right. They obviously haven't worked diligently enough. Things like this just feed the people who are hesitant to get vaccinated or to go along with anything else to protect themselves and others from Covid.

[hamsterjill]

3. Absolutely.

It feeds into the narrative that much of the “professional” tests administered may be questionable, too.

They definitely need to get this stuff right.

[BumRushDaShow]

4. There are hundreds of test kits approved under EUAs

including the most "accurate" - PCR (analysis must be done by a lab but many offer at-home swab collection to be sent out), antibody (analysis normally done by a lab but one offers at-home swab collection to be sent out), and antigen tests (the last one I think having the options for "home" strips for at-home/worksite analysis like the OP article, but can also be lab-analyzed).