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What is a ‘CE’ mark and why is it on a recalled COVID-19 at-home test?
Two COVID-19 fast exams have comparable names and appears, however there are some key variations and markings to search for, together with in case you purchased in bulk.
The Meals and Drug Administration is placing out one other warning about an at-home COVID-19 take a look at that isn’t licensed to be used within the U.S., however has the same sounding title and bundle look as one that’s OK to make use of in America.
Each have the title “Flowflex” and have similar title logos. However there are variations in product title and packaging to maintain an eye fixed out for.
The one to keep away from — which was recalled on January 9 — is the “Flowflex SARS-CoV-2 Antigen Fast Check (Self-Testing).” ACON mentioned in its recall discover that it’s an “unauthorized, adulterated and misbranded counterfeit product.”
One approach to establish it’s that it is available in a darkish blue field. One other is that that field is marked with the letters “CE” on the underside of the entrance label. This “CE” mark means it’s licensed to be used the European Union and different international locations, however not essentially within the U.S.
The recalled one will even say on the aspect panel that it’s from ACON Biotech (Hangzhou) Co., Ltd. in China.
The one which has obtained the OK to make use of within the U.S. is the “Flowflex COVID-19 Antigen Dwelling Check.” This one is available in a white field and doesn’t have the “CE” mark. And the aspect panel says it comes from ACON Laboratories, Inc. in San Diego.
Some folks have famous on social media that they imagine they’ve purchased the recalled one at Costco. They could be thrown by the majority packaging. The one bought at Costco is the licensed “Flowflex COVID-19 Antigen Dwelling Check” — however it’s bought as a five-pack and will have a white field positioned in a bigger turquoise field. That may very well be inflicting some confusion. The bigger field additionally doesn’t have the “CE” mark.
The recalled “Flowflex SARS-CoV-2 Antigen Fast Check (Self-Testing)” might result in inaccurate take a look at outcomes, in response to the FDA. That features false unfavorable or false constructive outcomes.
A false unfavorable would imply somebody exams unfavorable for COVID-19 when they’re truly constructive. That might lead the affected person to not search therapy for COVID-19.
A false constructive would imply somebody exams constructive for COVID-19 when they’re truly unfavorable. That particular person may have another ailment that they fail to get correct therapy for as a result of they incorrectly imagine they had been contaminated with the coronavirus.
ACON Laboratories mentioned it has not obtained reviews of hostile occasions associated to the recall.
