Pregnancy Test Recall in Canada Puts Some Positive Results in Doubt

For something so small, a pregnancy test carries an enormous amount of weight, because a single faint line can change how someone pictures the next year of their life. That is why Health Canada's latest notice deserves attention, since it warns that one manufacturer's tests may be answering yes when the true answer is no.

Health Canada has posted a pregnancy test recall for hCG One Step Pregnancy Tests made by Innovacon, Inc. The agency warns that the products may detect the pregnancy hormone at levels below their stated sensitivity, which can produce false positive results in people who aren't pregnant. According to Health Canada's recall notice, the company is updating its package insert to note that low hormone levels can occur at or after the start of perimenopause, the years leading up to menopause, and that anyone reading a result should keep this in mind.

The bottom line. The recall covers every lot of two Innovacon products: a test device for urine or serum and a urine strip. Health Canada addressed the notice to healthcare settings, so the recall most likely affects people who recently had a pregnancy test at a clinic or lab. Any surprising result, from any brand, is best confirmed with a blood test.

Key takeaways

Health Canada published the Type II recall, ID RA-82718, on October 2, 2026, and updated it on October 5.

Affected products are the hCG One Step Pregnancy Test Device (Urine/Serum), catalogue FHC-202, and Test Strip (Urine), catalogue FHC-101, in all lots.

The products may react to hormone levels below their stated sensitivity, which can cause false positives.

In early pregnancy, the hormone roughly doubles every two to three days, according to Mayo Clinic.

Which recalled tests should you know about?

The notice lists two products, both made by Innovacon, Inc. of San Diego, and the recall covers all lots of both. The first is the hCG One Step Pregnancy Test Device, catalogue number FHC-202, which can test urine or serum, the clear liquid part of blood. The second is the hCG One Step Pregnancy Test Strip for urine, catalogue number FHC-101. Health Canada lists the audience as healthcare and classifies the recalled tests as a Type II recall, the middle of its three risk levels.

That last detail tells readers a good deal about who should pay attention. Serum testing happens in clinics and labs, and the notice doesn't name any retail brand, which suggests this recall mainly concerns results people received through a healthcare provider. Health Canada's instruction is to contact the manufacturer for more information, and recall notices like this one are worth a two-minute read whenever they touch your care, much like Health Canada's recent action against an unauthorized peptide seller.

How can a false positive pregnancy test happen at all?

Pregnancy tests look for human chorionic gonadotropin, or HCG, a hormone made by the placenta once a fertilized egg implants in the uterus. In early pregnancy, the amount in blood and urine roughly doubles every two to three days, according to Mayo Clinic's guide to home pregnancy tests. Manufacturers design each test to turn positive only once HCG crosses a set threshold, and the recalled products appear to react below that line.

Small amounts of HCG can show up for reasons that have nothing to do with pregnancy. Mayo Clinic notes that a false positive pregnancy test can follow a very early miscarriage, come soon after fertility medicine that contains HCG, or show up with certain ovarian problems or around menopause. A test that trips at very low levels can turn those traces into a line on the stick. Hormone questions come up with birth control too, and Medimap has covered what one study found about birth control and brain tumour risk.

What should you do if you had a positive result at a clinic?

This pregnancy test recall matters most if you had a positive result at a clinic recently and other signs don't line up, and a few simple steps will sort out the uncertainty.

Ask which test the clinic used. Your clinic or lab can tell you whether the result came from one of the recalled products.

Hold off on big decisions. Wait for confirmation before acting on that result in either direction.

Ask for a blood test. A blood test can measure the actual amount of HCG and gives a far more reliable answer than a single strip.

Report a problem. If you think a recalled test affected your care, you can report a health or safety concern to Health Canada.

A false positive can do real harm, bringing emotional whiplash, unnecessary appointments and, for someone trying to conceive, genuine heartbreak when the result turns out to be wrong. If you're still waiting for a family doctor, a walk-in clinic can order the blood test for you.

How do you give a home pregnancy test its best chance?

Even a test that has nothing to do with any recall can mislead you now and then. Many brands claim 99 percent accuracy, yet several things can nudge a home pregnancy test the wrong way. Irregular periods make it hard to know when a period was actually due, and false negatives are more likely when you test too early, before HCG has had time to build. The most accurate results usually come from the first day after a missed period.

To give any test its best chance, wait until at least the day after a missed period, follow the instructions exactly, read the result within the time window printed on the package, and treat any surprise, positive or negative, as a reason to confirm. Pregnancy brings plenty of other questions, such as how heat exposure during pregnancy may affect a developing brain, and a provider can help with those too.

Still have questions about the Health Canada recall?

These short answers cover what people most want to know about the Health Canada recall and what it means for them.

Are drugstore pregnancy tests part of this recall?

The pregnancy test recall names two Innovacon products, catalogue numbers FHC-202 and FHC-101, and lists healthcare as its audience without naming any retail brand. If you're unsure about a test in your cupboard, check the manufacturer and catalogue number on the box against Health Canada's notice, or ask a pharmacist to look it up with you.

Can you get a false positive pregnancy test in your 40s?

A false positive in your 40s is possible, because Health Canada's notice says low HCG levels can occur at or after the start of perimenopause, which is why the manufacturer is updating its package insert. A very sensitive test may read those small amounts as positive, so an unexpected result at this stage of life is worth confirming with a blood test.

Is a blood test more accurate than a urine pregnancy test?

A blood test is generally more reliable because it can measure how much HCG is present rather than simply flagging whether it crosses a threshold. Repeating it a couple of days apart also shows whether levels are rising the way they should in early pregnancy. That makes it the best way to confirm a surprising home or clinic result.

When is the best time to take a pregnancy test?

The most accurate time is usually from the first day after a missed period, once HCG has had time to build. Testing earlier raises the chance of a false negative. If your cycles are irregular, wait a little longer or take a second test a few days later, and confirm any surprising result with a healthcare provider.

Your next step. If a test has left you with more questions than answers, a quick blood test can settle the matter. Browse more Canadian health news on the Medimap Health Hub, or check real-time walk-in clinic wait times near you and get a definitive answer today instead of staring at a second stick.

Disclaimer. This article is for general information only and is not medical advice. It does not replace an assessment by a qualified healthcare provider, and Medimap does not diagnose or treat. If you think you are having a medical emergency, call 911 or go to your nearest emergency department.