The Australia-based company Ellume announced it is pulling 427,000 of its COVID-19 home test kits.
Ellume says some of the kits delivered false-positive results at higher rates.
According to the company, about 42,000 tests out of the lots yielded positive results.
They would not say how many were false positives.
The tests were shipped from April through August and sold at major retailers including Walmart, CVS, Target and Amazon.
The Department of Defense even used them.
According to the company, it has isolated the cause and affected customers will be notified through e-mail or its COVID-19 home test app.
Ellume was the first company to receive FDA authorization to sell consumers COVID-19 home test kits.
the Kits deliver results in minutes without the need for a prescription.
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