Nearly 200,000 SARS-CoV-2 virus test kits in the US were recalled due to a false positive error

On October 6, medical device manufacturer Ellume (Australia) announced that it had recalled nearly 200,000 rapid test kits for SARS-CoV-2 virus in the US market due to a manufacturing error leading to positive results. fake.

Employees check rapid testing kits for the SARS-CoV-2 virus at Ellume Medical Equipment Manufacturing Company in Brisbane, Australia, December 21, 2020. File photo: AFP
Employees check rapid testing kits for the SARS-CoV-2 virus at Ellume Medical Equipment Manufacturing Company in Brisbane, Australia, December 21, 2020. File photo: AFP

A day earlier, the US Food and Drug Administration (FDA) issued a warning that many of Ellume's test kits are likely to give false positive results due to a recently discovered manufacturing defect. but negative results do not seem to be affected by this error. The agency also said it is working closely with Ellume to evaluate its manufacturing inspection process and other remedial measures to ensure the issue is resolved.

Talking to the press on October 6, a spokesman for Ellume confirmed that out of a total of 3.5 million kits shipped to the US, 195,000 had the above errors, including test kits approved by the Ministry of Defense. US allocation to public health programs. Earlier, on October 1, Ellume said it was asked to voluntarily recall the product after the rate of false positive results in some shipments was higher than expected.

Ellume founder Sean Parsons apologized to customers and stakeholders, and pledged that the company would make every effort to correct errors to ensure product accuracy. The company says it has identified the cause of the problem and implemented additional control measures, and continues to distribute test kits to US retailers.

Last year, Ellume's SARS-CoV-2 home test kit became the first product of its kind to be approved for emergency use in the US. Ellume, based in Brisbane, signed a deal to supply $300 million worth of test kits with the US earlier this year.

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