Two COVID-19 quick tests have similar names and looks, but there are some important differences and markings to look for, including if you bought in bulk.
That The Food and Drug Administration issues another warning about one home COVID-19 test which is not approved for use in the United States, but has a similar name and package appearance as one that is OK to use in America.
Both have the name “Flowflex” and have identical name logos. But there are differences in product title and packaging to keep an eye on.
The one to avoid – which was revoked on 9 January – is the “Flowflex SARS-CoV-2 Antigen Rapid Test.” ACON said in its recall notice that it is an “unauthorized, counterfeit and mislabeled counterfeit product.”
One way to identify it is that it comes in a dark blue box. Another is that the box is marked with the letters “CE” at the bottom of the front label. This “CE” mark means that it is approved for use in the EU and other countries, but not necessarily in the US
The recalled will also say on the sidebar that it is from ACON Biotech (Hangzhou) Co., Ltd. in China.
The one that has received OK for use in the United States is the “Flowflex COVID-19 Antigen Home Test.” This one comes in a white box and does not have the “CE” mark. And the sidebar says it’s from ACON Laboratories, Inc. in San Diego.
Some people have noticed on social media that they think they have bought the recalled one from Costco. They can be thrown away by the bulk packaging. The one sold at Costco is the authorized “Flowflex COVID-19 Antigen Home Test” – but it is sold as a five-pack and may have a white box placed in a larger turquoise box. It can cause confusion. The larger box also does not have the “CE” mark.
The withdrawn “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test)” could lead to inaccurate test results, according to the FDA. It includes false negative or false positive results.
A false negative would mean that someone tests negative for COVID-19 when in fact they are positive. This may prevent the patient from seeking treatment for COVID-19.
A false positive would mean that someone tests positive for COVID-19 when in fact they are negative. This person may have another disorder that they are not getting proper treatment for because they mistakenly think they were infected with coronavirus.
ACON Laboratories said it has not received any reports of adverse events related to the recall.