Canada-wide recall issued for pregnancy tests that may produce false positives
Health Canada warned Oct. 5 that Innovacon Inc.'s hCG one-step pregnancy tests may detect hormone levels below their stated threshold, potentially showing positive for people who aren't pregnant.
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Health Canada issued a Canada-wide recall on October 5 for hCG one-step pregnancy tests manufactured by Innovacon Inc. after finding they may detect the hormone hCG below the sensitivity threshold stated on the package — meaning someone not pregnant could receive a positive result.
The recall affects two models: FHC-101 and FHC-202, sold as both test devices and test strips. The products have been available at pharmacies, Walmart, and Amazon.
Low hCG levels can occur during or around the onset of perimenopause, and Health Canada is updating the product package insert to note this connection. At-home pregnancy tests typically advertise accuracy rates up to 99 per cent, though timing, medications, underlying health factors, and test usage can all affect results and contribute to false positives.
Health Canada is advising customers to contact the manufacturer for a refund. For anyone who receives an unexpected positive result, Health Canada recommends speaking with a health-care professional and confirming the result with another test.
By the numbers
Which pregnancy test models are affected by the Canada-wide recall?
Health Canada recalled two models of hCG one-step pregnancy tests made by Innovacon Inc.: FHC-101 and FHC-202, sold as both test devices and test strips.
What's the problem with these pregnancy tests?
The tests may detect hCG hormone levels below the sensitivity threshold stated on the package, potentially showing a positive result for people who are not pregnant.
Where were these pregnancy tests sold?
The affected pregnancy tests were available at pharmacies, Walmart, and Amazon.
