Health Canada Warns Recalled Pregnancy Tests May Give False Positives

A pregnancy test is shown in a file photo. Health Canada 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. Shutterstock

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.”

Rapid response pregnancy tests are at-home urine tests designed to detect the pregnancy hormone human chorionic gonadotropin (hCG) quickly, often providing results in less than three minutes.

Most brands claim more than 99 percent accuracy from the day of the expected or missed period.

A false-positive can happen if a woman has had a pregnancy loss soon after the fertilized egg attached to the uterine lining, according to the Mayo Clinic. A false-positive can also occur if a pregnancy test is taken soon after taking fertility medicine that contains HCG.

HCG only exists in the body during pregnancy but ovarian complications and menopausal conditions may produce false positive test outcomes, the clinic added.

Menstrual cycle irregularities may similarly influence the accuracy of pregnancy test outcomes, because they make it more challenging to establish when a period should start.

Other pregnancy tests have previously been recalled in Canada.

A recall was issued by Health Canada in 2011 for Clinitest HCG Tests for safety concerns, Durex Canada recalled tests over inconsistent readings, and Confirm Clearly Kits were pulled from the market in 2002 due to inconsistent results and high false-positive rates.