Another Flowflex COVID-19 home test warning issued by FDA

Two COVID-19 fast tests have equivalent names and appears, but there are some crucial discrepancies and markings to appear for, which include if you acquired in bulk.

The Food and Drug Administration is placing out a different warning about an at-dwelling COVID-19 examination that is not approved for use in the U.S., but has a very similar sounding name and package deal look as a person that is Okay to use in America.

Each have the identify “Flowflex” and have identical name logos. But there are variances in product or service title and packaging to retain an eye out for.

The a single to stay clear of — which was recalled on January 9 — is the “Flowflex SARS-CoV-2 Antigen Quick Check (Self-Tests).” ACON mentioned in its recall recognize that it is an “unauthorized, adulterated and misbranded counterfeit product.” 

One way to identify it is that it comes in a dim blue box. Another is that that box is marked with the letters “CE” on the base of the entrance label. This “CE” mark means it is authorized for use the European Union and other countries, but not essentially in the U.S.

The recalled 1 will also say on the side panel that it is from ACON Biotech (Hangzhou) Co., Ltd. in China.

The one that has been given the Ok to use in the U.S. is the “Flowflex COVID-19 Antigen Dwelling Check.” This one particular arrives in a white box and does not have the “CE” mark. And the facet panel states it arrives from ACON Laboratories, Inc. in San Diego.

Some persons have pointed out on social media that they imagine they have acquired the recalled a person at Costco. They may be thrown by the bulk packaging. The a person offered at Costco is the authorized “Flowflex COVID-19 Antigen House Exam” — but it is bought as a five-pack and may perhaps have a white box placed in a larger turquoise box. That could be triggering some confusion. The greater box also does not have the “CE” mark.

The recalled “Flowflex SARS-CoV-2 Antigen Fast Test (Self-Screening)” may guide to inaccurate take a look at effects, according to the Food and drug administration. That consists of phony detrimental or phony positive final results.

A untrue adverse would imply someone tests detrimental for COVID-19 when they are truly constructive. That could lead the patient to not request treatment for COVID-19.

A bogus beneficial would mean another person tests positive for COVID-19 when they are really unfavorable. That man or woman could have some other ailment that they fail to get appropriate cure for due to the fact they incorrectly consider they were being contaminated with the coronavirus.

ACON Laboratories reported it has not gained reviews of adverse gatherings relevant to the recall.

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