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Ellume, an Australian company that supplied over 3.5 million FDA-approved Covid-19 testing kits to the US, has now recalled nearly 200,000 of them due to an unspecified manufacturing issue that resulted in false positives.

The Food and Drug Administration issued a notice on Tuesday alerting the public of “the potential for false positive results” with certain lots of Ellume’s Covid-19 Home Test, a rapid antigen kit used to detect the coronavirus using nasal swabs and a smartphone app.

Today, the @US_FDA issued a safety communication to alert test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume #COVID19 Home Test due to a recently identified manufacturing issue. pic.twitter.com/uYSJ9U4DBu

— FDA Medical Devices (@FDADeviceInfo) October 5, 2021

“Negative results do not appear to be affected by the manufacturing issue,” the FDA said, adding it is “working closely” with Ellume to assess “corrective steps” going forward.

People who used an Elume kit and received a positive result were instructed to contact their healthcare provider for a follow-up. Everyone who owns a kit is urged to check the Ellume-provided list of problematic lots, sent out between April and August this year, and request a replacement after submitting receipts.

Ellume CEO Dr. Sean Parsons said the company noticed the false positive result from specific product lots “in recent weeks” and isolated the cause. However, the company declined to elaborate what was causing the problem, citing trade secrets.

“The increase in false positives was the result of a supply chain issue with one of the test components. Because of the proprietary information involved in the manufacturing process, we cannot offer more specifics,” an Ellume spokesperson said in a statement.

While neither the FDA nor Ellume gave the exact amount of kits that are being recalled, the New York Times said the number was “nearly 200,000.” A total of 427,000 kits sent to the US have been affected by the unspecified issue, and half have already been used, resulting in about 42,000 positive results, the paper said. It was unclear how many of those positives may have been false.

Ellume has shipped approximately 3.5 million test kits to the US after receiving FDA emergency use authorization in December as the first over-the-counter completely at-home Covid-19 test.

At least four of the lots listed on Ellume’s recall page were sent to the US Department of Defense. The Pentagon awarded Ellume a $238 million contract in February, to increase the production of its tests in the US.

Meanwhile, the FDA on Monday issued an authorization to Flowflex, another at-home antigen test for Covid-19, made by the California-based ACON Laboratories.

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