FDA warns use of these pregnancy test kits

Published March 5, 2021, 10:07 AM

by Jane Kingsu-Cheng

With pregnancy rates going higher this pandemic, parents and soon-to-be parents are stocking up on pregnancy test kits.

The Food and Drug Administration (FDA) issued a warning on two unregistered pregnancy kits: Fertility series HCG colloidal gold rapid screen test easy pregnancy test and Sweet Honey pregnancy test kit (in foreign characters).

According to advisory number 2021-0237, the FDA announced on their website that these two products have not been registered with no corresponding Product Registration Certificate. “Since this unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.”

FDA reminds the public not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificate is issued. Regulatory actions and sanctions will be strictly implemented.

You can verify FDA-approved products with the search feature on their website www.fda.gov.ph or look for the FDA Registration number on the product label in the form of either IVDR-xxx or RR-xxx.