A typical fast at-home COVID check has grow to be the topic of a current product recall over considerations the antigen check hasn’t obtained correct U.S. authorization.
The Food and Drug Administration issued a recall late final month for “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing),” a product bought at an unknown variety of pharmacies and distributed by native well being officers. The easy-to-use at-home check has been accepted in European and different markets, however didn’t obtain the required emergency use authorization by the FDA.
The recall of the check, which the federal government estimates has 200,000 in U.S. circulation, could confuse shoppers between to Flowflex branded antigen checks.
Packaged in a white field and given the right emergency use authorization, the “Flowflex™ COVID-19 Antigen Home Test” is accepted within the U.S.
A recall discover by ACON Laboratories identifies a fast antigen check (left) in blue packaging that has been recalled, subsequent to its U.S. accepted product (proper) packaged in a white field.
Consumers in possession of the unauthorized check are inspired by the FDA to get rid of the product and if already used to detect a doable COVID an infection, search a further check from a federally accepted supplier.
The producer of the Flowflex checks, ACON Laboratories, stated it was conscious of the “unauthorized, adulterated and misbranded counterfeit product” and issued a recall order on Jan. 9.
“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 press release from the producer stated this week.
ACON released a side-by-side comparability of the 2 merchandise hoping to assist U.S. shoppers differentiate between the recalled check and the one cleared for emergency use.
As of this week, the producer stated it has not obtained any studies of “adverse events” associated to both check and has issued the recall “out of an abundance of caution.”
The recall caught the eye of public well being officers in at the very least one New York county, who issued a discover to residents on Friday.
The authorities of Orange County postponed the beforehand scheduled distribution of the recalled checks deliberate for Monroe, and introduced that anybody who obtained the check at Wallkill and New Windsor occasions can alternate their antigen check for a brand new one at a later occasion.
FDA Recalls 200,000 Unauthorized Flowflex COVID Rapid Tests.For More Article Visit PSIEV