Is Rapid Really a Good Thing? — FDA-Approved Over-the-Counter COVID-19 Test Recalled

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley

Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume.

The reason? Way too many false positive results.

“At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic,” company CEO Sean Parsons said in a statement. “To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result.”

Imagine the initial shock of testing positive for COVID-19 amid a global pandemic closing in on its second year, and then imagine the secondary shock of discovering the result was erroneous – and of realizing the disease still could be contracted.

“You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust,” Parsons said. “We understand you are counting on us to do nothing less.”

The voluntary recall affects kits sold in major pharmacies and other retail outlets and kits provided to the Department of Defense. Half the kits are in unused lots. Of the other half, over 10,000 false positive results are suspected. The debacle could not have come at a worse stage in the health crisis.

“This recall yanks hundreds of thousands of rapid COVID-19 tests off the shelves at a time when demand for these tests has already skyrocketed,” ABC News reports. “Amid shortages, many of the major retail pharmacy stores announced they are limiting purchases to contend with supply constraints.”

So far, the COVID-19 rapid test kits proved horrible. Their efficacy has been bad from the beginning. In September 2021, a few weeks before the Ellume recall, the Alinity m SARS-CoV-2 AMP Kit, by American manufacturer Abbott, came under scrutiny for false positive results. The U.S. Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Abbott product in May 2020, and it was granted a revision in August 2021. The FDA issued an EUA for the Ellume product, which, unlike the Abbott product, is an over-the-counter at-home test and the first to receive such government status. It is fairly easy to administer and involves swabbing the nostrils, dipping the sample into a fluid and using a dropper to transfer everything to a Bluetooth-enabled analyzer. Fifteen minutes later, the results are retrievable via a smart-phone app.

“No matter how accurate a test is, there is always a potential for false-positive and false-negative results,” Self magazine reports. “Rapid tests like these have varying rates of false-positive results depending on the specific brand and whether or not the person taking the test has noticeable COVID-19 symptoms. In general, rapid tests more accurately identify positive cases when people have symptoms and when the overall prevalence of the virus is higher.…”

Here is what the FDA recommends for consumers:

  • Check the lot numbers of any Ellume kits purchased against the lot numbers on Ellume’s Web site.
  • If a positive test result occurs from a kit with a matching lot number, request a COVID-19 molecular diagnostic test for confirmation.
  • If there is an unused kit with a matching lot number, follow the prompts on Ellume’s Web site to obtain a replacement product.

“You should not assume that you had COVID-19 or have immunity to COVID-19,” according to the FDA. “You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention’s guidelines.”

The FDA said it will keep the public informed if any new information surfaces on the Ellume product.

“The FDA regularly monitors the post-authorization use of tests, including reports of problems with test performance or results, and is providing this information to help educate patients, caregivers, and health care providers,” the agency states. “The FDA is continuing to work with Ellume to assess the company’s additional manufacturing checks and other corrective steps to address the reason for the manufacturing issue and help ensure that it is resolved.”

To report a false positive test result or any other problem with the Ellume product, fill out the MedWatch Online Voluntary Reporting Form, call the Division of Industry and Consumer Education at 800-638-2041 or 301-796-7100 or email

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Searcy Denney Scarola Barnhart & Shipley | Attorney Advertising

Written by:

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.