Health Canada has issued a Canada-wide recall for certain at-home pregnancy tests after the products were found to potentially produce false-positive results.
The recall notice, published Oct. 5, affects hCG one-step pregnancy tests manufactured by Innovacon Inc., including both the pregnancy test device and pregnancy test strip. The affected models are FHC-101 and FHC-202.
The tests may detect very low levels of human chorionic gonadotropin (hCG) — the hormone associated with pregnancy — below the test's stated sensitivity. That means someone who isn't actually pregnant could potentially receive a positive result.
Health Canada says the product's package insert is being updated to note that low hCG levels can occur during or around the onset of perimenopause, which may be important to consider when interpreting a positive result.
While many at-home pregnancy tests advertise accuracy rates of up to 99 per cent, no test is foolproof. Timing, current medications, underlying health factors, and the way a test is used can all affect results, including the possibility of a false positive, according to medical professionals.
The recalled products are often found at pharmacies, major retailers like Walmart and even sold online through Amazon.
Health Canada is advising customers who have questions about the recalled products to contact the manufacturer for additional information or to inquire about a refund.
If you've recently received an unexpected positive result from one of these tests, it may be worth speaking with a health-care professional and confirming the result with another test.
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