Key Takeaways
- Health Canada issued Type II recalls for specified Innovacon and Abbott hCG pregnancy testing products.
- The affected devices may detect low hCG levels below their stated sensitivity, potentially causing false-positive results.
- The notices concern specific healthcare products, not every home pregnancy test sold in Canada.
Canada Recalls Pregnancy Tests Over False Positive Results
Imagine taking a pregnancy test, seeing a positive result — and later discovering you weren't actually pregnant.
Health Canada has issued Type II recalls for certain hCG pregnancy testing products because they may produce false-positive results in people who are not pregnant.
The recalls are related to the performance of the medical devices and cover all lots of several affected products.
Which Pregnancy Tests Are Affected?
One Health Canada recall covers two products from Innovacon:
- hCG One Step Pregnancy Test Device (Urine/Serum) — model FHC-202
- hCG One Step Pregnancy Test Strip (Urine) — model FHC-101
Health Canada says all lots of both products are affected. The recall is classified as Type II and has a recall date of September 21, 2026.
A separate Health Canada notice covers two Abbott Rapid Diagnostics products:
- hCG Combo Cassette 25 — catalogue number 92225CA
- hCG Cassette 25 — catalogue number 92217CA
All lots of those products are also included in the Type II recall.
Why Could Someone Get a False Positive?
Pregnancy tests work by detecting human chorionic gonadotropin, or hCG.
According to Health Canada, the affected products may detect low levels of hCG below their stated assay sensitivity. That means a sample from someone who is not pregnant could potentially produce a positive result.
Health Canada also says the package inserts are being updated to explain that low hCG levels can occur at or after the onset of perimenopause, which should be considered when interpreting test results.
Does This Mean All Pregnancy Tests in Canada Are Affected?
No.
Health Canada's notices identify specific products and model or catalogue numbers. The stated audience for both recalls is healthcare, so this should not be interpreted as a recall of every home pregnancy test available at Canadian pharmacies or retailers.
Anyone dealing with an affected product who needs more information is advised by Health Canada to contact the manufacturer.