It’s estimated that over 200,000 units of the at-home test have been in U.S. circulation.
"COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results," a statement from the manufacturer said this week.a side-by-side comparison of the two products hoping to help U.S. consumers differentiate between the recalled test and the one cleared for emergency use.
As of this week, the manufacturer said it has not received any reports of"adverse events" related to either test and has issued the recall"out of an abundance of caution." The recall caught the attention of public health officials in at least one New York county, who issued a notice to residents on Friday.
The government of Orange County postponed the previously scheduled distribution of the recalled tests planned for Monroe, and announced that anyone who received the test at Wallkill and New Windsor events can exchange their antigen test for a new one at a later event.
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