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[HEALTH] · Canada · 2 sources

Health Canada recalls Innovacon Inc. pregnancy tests

pregnancy test recall false positive HCG one-step tests Innovacon Inc. Health Canada safety notice

Health Canada has issued a safety notice and recall for HCG one-step pregnancy tests manufactured by Innovacon Inc. due to concerns regarding potential false positive results.

The agency stated that the product may detect low levels of human chorionic gonadotropin (HCG) below the stated assay sensitivity. This could lead to false-positive results in non-pregnant individuals. The package insert for the tests is being updated to advise customers that low HCG levels can occur during or after the onset of perimenopause.

While many home pregnancy tests claim high accuracy, factors such as fertility medications containing HCG, recent miscarriages, or ovarian issues can influence results. HCG is a hormone typically produced by the placenta after a fertilized egg implants in the uterus.

Entities

Health Canada · Innovacon Inc. · Mayo Clinic

Sources

Health Canada warns of possible false positives in pregnancy test recall [thecrystaleyes.com]
Health Canada warns of possible false positives in pregnancy test recall - National [globalnews.ca]