FDA warns against use of unregistered Ecotest antigen kit

MANILA, Philippines — The Food and Drug Administration (FDA) has asked the public not to “patronize and use” the Ecotest COVID-19 Antigen Nasal Test Kit, which is not registered.

In FDA Advisory 2022-0025 signed by acting director general Oscar Gutierrez Jr., the agency has warned health care professionals and the general public that the antigen test kit “is not certified.”

Gutierrez said they also verified through post marketing surveillance that the product has no corresponding Special Certification from the agency.

“Since this uncertified COVID-19 test kit has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” he noted.

He added this is a violation of Republic Act 9711 or the FDA Act of 2009 which prohibits the “manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization.”

The FDA had also reiterated its warning that online selling of all types of FDA certified COVID-19 test kits, such as RT-PCR, antibody, antigen based, is “strictly prohibited.”

“All concerned establishments are warned not to distribute, advertise, or sell the said violative COVID-19 test kit until the FDA Special Certificate is issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” the advisory reads.

The agency also asked all local government units and law enforcement agencies to ensure that the product is “not sold or made available in the market or areas of jurisdiction.”

The FDA had also urged the Bureau of Customs to “restrain” entry of the product into the country.