THE Food and Drug Administration (FDA) yesterday warned the public against buying and using the GeneFinder® COVID-19 Ag Self-Test kit brand, which has yet to get the green light from the agency for its public marketing and sale.
FDA Advisory No.2022-0415 said the self-test kit brand has not undergone the required government process.
“The FDA warns all healthcare professionals and the general public not to purchase and use the uncertified COVID-19 test kit GeneFinder® COVID-19 Ag Self-Test,” said the FDA, adding that it has “verified through post-marketing surveillance that the above mentioned COVID-19 test kit is not certified and no corresponding Special Certificate has been issued.”
It warned that use of the product may put to risk concerned individuals.
“Since this uncertified COVID-19 test kit has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety,” said FDA.
It reminded the public that the manufacture, importation, exportation, or sale of health products without the proper authorization is prohibited under the FDA Act of 2009.
“All concerned establishments are warned not to distribute, advertise, or sell the said violative COVID-19 test kit,” said the FDA, as it asked law enforcement agencies and local government units to ensure that the uncertified COVID testing kit is not sold or made available in the market or their areas of jurisdiction.
It likewise requested the Bureau of Customs to restrain the entry of the imported product into the country.
