Health Canada is issuing a safety notice and recall for a brand of home pregnancy test because they may show a false positive result.
The health agency is recalling Innovacon Inc.’s hCG One Step Pregnancy Tests because they may detect very low hormone levels and give false positive results to women who are not pregnant.
“The product may detect low levels of HCG below the stated assay sensitivity,” the agency said in its Oct. 5 advisory.
The recall includes hCG One Step pregnancy test devices with model number FHC-202 and hCG One Step pregnancy test strips with model number FHC-101.
“The package insert is being updated to note that low HCG levels can occur at or after onset of perimenopause,” the advisory added. “Customers should consider this when interpreting results.”…