Health Canada has issued a Canada-wide recall for specific Innovacon hCG one-step pregnancy tests after concerns they may produce false-positive results.
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Health Canada has issued a Canada-wide recall for certain at-home pregnancy tests that could potentially produce false-positive results.
The recall notice, published Oct. 5, applies to 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.
Health Canada says the tests may detect very low levels of human chorionic gonadotropin (hCG) — the hormone associated with pregnancy — below the test’s stated sensitivity, meaning someone who is not actually pregnant could potentially receive a positive result.
The notice also says the package insert is being updated to note that low hCG levels can occur during or around the onset of perimenopause, which may be important when interpreting a positive result.
Health Canada advises customers who have questions about the recalled products to contact the manufacturer for additional information or to inquire about a refund.
The notice also says that if someone received an unexpected positive result from one of the recalled tests, they may want to speak with a health-care professional and confirm the result with another test.
According to the recall information, the recalled tests are often found at pharmacies, major retailers including Walmart, and are also sold online through Amazon.
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