Health Canada Issues Type II Recall of Innovacon hCG Pregnancy Tests 2026

Health Canada has announced a Type II recall of two Innovacon, Inc. hCG One Step Pregnancy Test products over a performance problem that could produce false positive results. The recall, listed under identification number RA-82718, was published on October 2, 2026, and covers every lot of the affected tests.

The notice was issued by Health Canada’s Medical devices program and classifies the action as a health product recall in the Chemistry category of medical devices. The listed audience is Healthcare.

Regulatory Response

Health Canada assigned the recall a Type II classification. The notice says the manufacturer, Innovacon, Inc., is updating the package insert for the tests. The updated insert will note that low HCG levels can occur at or after the onset of perimenopause.

The notice asks customers to keep this in mind when interpreting results. It does not describe a product removal or replacement program. The only action it lists for consumers is to contact the manufacturer for more information.

Products Affected by This Recall

Two products are named in the recall. In both cases, every lot is affected.

• hCG One Step Pregnancy Test Device (Urine/Serum): model or catalogue number FHC-202, all lots
• hCG One Step Pregnancy Test Strip (Urine): model or catalogue number FHC-101, all lots

Because the recall covers all lots, there are no individual lot numbers or expiry dates to check. Anyone who has one of these products should check the model number printed on the packaging against the two listed above.

What Triggered the Recall

The issue is classified as a medical device performance problem. According to Health Canada, the tests may detect low levels of HCG that fall below the assay sensitivity stated for the product. When that happens, a sample from a person who is not pregnant could return a false positive result.

HCG, or human chorionic gonadotropin, is the hormone that pregnancy tests are designed to detect. A test that reacts to levels below its stated sensitivity may show a positive result when the hormone is present only at a very low level.

The notice links this to perimenopause, saying low HCG levels can occur at or after its onset. This is why the manufacturer is revising the package insert. The notice does not report any injuries or adverse events, and it does not say how many units are affected.

Who Should Be Concerned

The notice lists Healthcare as its audience. Clinics, laboratories and other professional settings that use the Innovacon FHC-202 device or FHC-101 strip are the most likely to be affected.

Individuals who bought or use these tests should also take note. A false positive can be confusing or distressing, and it may lead to unnecessary follow-up. The notice does not name retailers or distributors, and it does not give a sales period. It lists the manufacturer as Innovacon, Inc., located at 9942 Mesa Rim Road, San Diego, California, United States, 92121.

What Consumers Need to Do Now

The only action listed in the notice is to contact the manufacturer if you need more information. Based on the notice, a sensible approach is as follows:

• Check the model number on your hCG One Step Pregnancy Test against FHC-202 and FHC-101.
• If it matches, keep in mind that a positive result could be a false positive, particularly for someone at or after the onset of perimenopause.
• Do not rely on a positive result alone. Speak with a doctor or other healthcare professional about confirming it.
• Contact Innovacon, Inc. for further information about the recall and the updated package insert.

Health Canada’s notice does not announce a refund or replacement. Anyone who wants to know whether the manufacturer offers one should ask the company directly.

Quick Facts

• Recall number: RA-82718
• Recall class: Type II
• Published by: Health Canada
• Published date: 2026-10-02
• Manufacturer: Innovacon, Inc., San Diego, California
• Lots affected: All lots

From the Agency

In its notice, Health Canada states that 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. It adds that the package insert is being updated to note that low HCG levels can occur at or after the onset of perimenopause, and that customers should consider this when interpreting results.

Health Canada also lets members of the public subscribe to email updates on new and updated recalls and safety alerts. It accepts reports of health or safety concerns through its website.