Health Canada recalls two pregnancy test models over possible false positives

Health Canada issued a Canada-wide recall notice on Oct. 5 for certain at-home hCG one-step pregnancy tests made by Innovacon Inc. The recall covers both the pregnancy test device and strip, in models FHC-101 and FHC-202. The tests may detect very low levels of human chorionic gonadotropin (hCG), the hormone associated with pregnancy, below their stated sensitivity. As a result, someone who is not pregnant could receive a positive result.

Health Canada says the product insert is being updated to note that low hCG levels can occur during or around the onset of perimenopause, which may be relevant when interpreting a positive result. Medical professionals say that although 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 how a test is used can all affect results, including the possibility of a false positive.

The recalled products are often available at pharmacies and major retailers such as Walmart, and are also sold online through Amazon. Health Canada advises customers with questions to contact the manufacturer for more information or to ask about a refund. Anyone who has recently received an unexpected positive result from one of these tests may wish to speak with a health-care professional and confirm the result with another test.