Health Canada recalls Innovacon HCG pregnancy tests over false-positive risk

Health Canada has released a safety alert and initiated a recall of Innovacon Inc.'s HCG one-step pregnancy tests because they may generate false-positive outcomes. According to the notice, the devices can pick up HCG concentrations lower than the stated assay sensitivity, which could cause a positive result in individuals who are not pregnant. The agency will amend the package insert to explain that low HCG levels may occur at or after the start of perimenopause, and urges users to factor this into their interpretation.

The recall follows previous Canadian withdrawals of home pregnancy tests for various reliability issues. Health Canada recommends that consumers follow the updated guidance when using the tests.