Health Canada Recalls Innovacon Pregnancy Tests Over False-Positive Risk
Health Canada has issued a safety notice and recall for HCG one-step pregnancy tests manufactured by Innovacon Inc. because the devices may produce false-positive results in non-pregnant individuals. The product's package insert is being updated to warn that low levels of human chorionic gonadotropin can occur during perimenopause or after certain medical events.
Health Canada has issued a safety notice and recall for HCG one-step pregnancy tests manufactured by Innovacon Inc., warning that the devices may produce false-positive results when used by non-pregnant individuals. 
According to the agency, the recalled tests might detect low levels of human chorionic gonadotropin (HCG) that fall below the product's stated assay sensitivity. Rapid response pregnancy tests work by determining the presence of HCG in urine. During early pregnancy, the amount of HCG in blood and urine doubles every two to three days, and many home pregnancy tests claim 99 per cent accuracy.
However, low levels of HCG can also be present in people who are not pregnant. The package insert for the Innovacon tests is being updated to note that such levels can occur at or after the onset of perimenopause. Problems with the ovaries and menopause may also lead to a false-positive test result.
Other circumstances identified as potential causes of false positives include taking a pregnancy test soon after using fertility medicine containing HCG, or experiencing a miscarriage shortly after a fertilized egg attaches to the uterine lining.
Pregnancy tests have been recalled in Canada before for issues ranging from unreliable results to faulty packaging.