What you should know
- The Food and Drug Administration (or FDA for its acronym in English) issued a recall late last month for the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)”.
- The home use test has been approved in Europe and other markets, but has not received the required emergency use authorization by the FDA.
- Packaged in a white box and with the appropriate emergency use authorization, the “Flowflex™ COVID-19 Antigen Home Test” is approved in the US.
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NEW YORK — A rapid home test for COVID has been withdrawn from the market due to concerns that the antigen test has not received proper U.S. authorization.
The Food and Drug Administration (or FDA for its acronym in English) issued a recall late last month for the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)”, a product sold in a number unknown from pharmacies and distributed by local health officials. The home use test has been approved in Europe and other markets, but has not received the required emergency use authorization by the FDA.
The recall of the test, which the government estimates has 200,000 in circulation in the US, may confuse consumers among Flowflex brand antigen tests.
Packaged in a white box and with the appropriate emergency use authorization, the “Flowflex™ COVID-19 Antigen Home Test” is approved in the US.
The FDA encourages consumers in possession of the unauthorized test to discard the product and, if it has already been used to detect possible COVID infection, to seek additional testing from a federally approved provider.
The manufacturer of the Flowflex tests, ACON Laboratories, said it was aware of the “unauthorized, adulterated and mislabeled counterfeit product” and issued a recall order on January 9.
“COVID-19 antigen tests on the US market that lack FDA approval, authorization, or clearance may present a significant risk as they can lead to inaccurate test results, including false-negative test results.” or false positives,” said a statement from the manufacturer this week.
ACON published a side-by-side comparison of the two products in hopes of helping US consumers differentiate between the withdrawn test and the one approved for emergency use.
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As of this week, the manufacturer said it has not received any reports of “adverse events” related to any of the tests 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.
Orange County government postponed the previously scheduled distribution of the recalled tests planned for Monroe and announced that anyone who was tested at the Wallkill and New Windsor events can exchange their antigen test for a new one at a later event.
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