Though initially estimated to affect about 427,000 COVID-19 tests, the recall of Ellume’s rapid antigen at-home tests has since expanded to include more than quadruple that amount.
An FDA notice updated this week placed the count of affected test kits at more than 2.2 million. They’re labeled with more than 100 master lot codes, according to the Australian test maker, well above the 40 lots originally identified when Ellume initiated the recall on Oct. 1.
At that time, Ellume requested that anyone in possession of one of the affected tests—whether used or unused—return it to the company and seek out an alternate test, citing a heightened risk of receiving a false-positive result from certain lots of the Ellume COVID-19 Home Test.
Since then, the FDA has designated the voluntary recall a Class I event, indicating the highest risk of potential injury or death associated with the affected products. The agency said in this week’s statement that it has received 35 reports of false-positive results from the tests to date, with no deaths linked to the faulty kits.
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The flaw in the kits was attributed to an unspecified manufacturing issue. In a statement, the company said, “Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are continuing to work on resolving the issue that led to this recall.”
The at-home test kit includes a nasal swab, a vial of processing fluid and an analyzer. Once a swab sample is collected—from higher up in the nose than many other at-home tests—it’s diluted in the fluid. An included dropper is used to place a small amount of the mixture into the analyzer, which sends its findings to the user’s smartphone via Bluetooth within 15 minutes.
Ellume’s coronavirus test received emergency authorization from the FDA in December 2020, when it became the first over-the-counter, fully at-home kit authorized by the agency. Not long after, Ellume inked a $231.8 million deal with the U.S. government to expand production and availability of its tests.
The bulk of the affected tests, therefore, were distributed either by retailers like Amazon, Target and CVS or the U.S. Department of Defense. They were manufactured between February and August of this year and distributed beginning in April.
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Anyone who purchased an Ellume test between April and August can fill out an online form to determine whether their kit was affected by the manufacturing error. If so, they can request a replacement from the company and, if they received a positive result from the test in the last two weeks, should be immediately re-tested.
Negative results, meanwhile, are not affected by the manufacturing issue, the company said.
The FDA is also warning that those who received a positive result from one of the affected kits more than two weeks prior to learning about the recall should operate under the assumption that they didn’t actually have COVID and therefore do not have natural immunity to the coronavirus. Instead, according to the agency, they should continue to take safety precautions to protect themselves and those around them from the virus.