Pregnancy tests sold across Canada recalled over false-positive results
· Toronto Sun
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A recall for some faulty at-home pregnancy tests has been issued by Health Canada.
The affected products are hCG one-step pregnancy tests, manufactured by Innovacon, Inc., based in San Diego, Calif.
Possible false-positive results
The problem? They could produce a false-positive test result, which essentially means the test says you are pregnant — but you’re not.
The product “may detect low levels of HCG below the stated assay sensitivity which may result in false positive test results in samples from non-pregnant individuals,” reads Health Canada’s notice , which was published Monday. HCG stands for human chorionic gonadotropin, the hormone associated with pregnancy.
Both the pregnancy test strip and the device itself have been recalled, the agency added.
All lots for the device with the model number FHC-202 and the strips with the model number FHC-101 are affected.
What should you do?
According to the federal health agency, the product’s package insert is being updated to include a warning that low HCG levels can occur at or after onset of perimenopause — and should be noted when interpreting a positive result.
The recalled products are often found at pharmacies and retailers, including Walmart and London Drugs, and also sold online through Amazon.
For customers who have questions or want to inquire about a refund, Health Canada is advising you to contact the manufacturer for additional information.
Those who received an unexpected positive result from the product might want to consider speaking with a health-care professional and get re-tested.