THE Food and Drug Administration (FDA) yesterday warned the public against buying and using the the coronavirus disease (COVID-19) testing kit under the brand name “Partners COVID-19 Igg/Igm Rapid Test Cassette (WB/S/P).”
In Advisory No.2022-0609, the FDA said: “The FDA verified through post-marketing surveillance that the abovementioned COVID-19 test kit is not certified and no corresponding Special Certification has been issued.”
The health agency said the use of the product may pose danger to users, pointing out that “since this uncertified COVID-19 test kit has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.”
In addition, it said that the FDA Law of 2009 prohibits the manufacture, importation, exportation, sale, advertising, or sponsorship of health products without the proper authorization.
“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,” said FDA.
The FDA also asked all law enforcement agencies and local government units to ensure that the said product is not sold or made available in the market or areas of jurisdiction.
The FDA likewise urged the Bureau of Customs to restrain the entry of the said uncertified product.
