False Positive Risk Prompts Recall of Abbott hCG Cassettes in Canada 2026

Health Canada has published a Type II recall of two Abbott hCG cassette products after the devices were found to detect low levels of HCG below their stated assay sensitivity, which can produce false positive results in samples from non-pregnant individuals. The notice, posted on October 2, 2026, covers all lots of both products and is listed under identification number RA-82719.

The recall involves hCG Combo Cassette 25 and hCG Cassette 25, made by Abbott Rapid Diagnostics ULC of Ottawa, Ontario. The recall date recorded by Health Canada is September 21, 2026, and the notice is directed at the healthcare audience.

• Brand: Abbott Rapid Diagnostics ULC
• Products: hCG Combo Cassette 25 and hCG Cassette 25
• Affected lots: All lots
• Recall class: Type II
• Recall number: RA-82719
• Issue: Medical devices – Performance

Products Affected by This Recall

Two catalogue numbers are named in the notice. The hCG Combo Cassette 25 carries model or catalogue number 92225CA. The hCG Cassette 25 carries model or catalogue number 92217CA. For both, Health Canada lists the affected lot or serial numbers simply as all lots, so no individual lot can be treated as outside the scope of the notice.

Health Canada classifies the products under Health products – Medical devices – Chemistry. The notice does not list a UPC, a unit count or a distribution list.

What Triggered the Recall

According to the notice, the cassettes may detect low levels of HCG that fall below the assay sensitivity stated for the product. HCG, or human chorionic gonadotropin, is the hormone these cassettes are designed to detect. When a device reacts to HCG below its stated sensitivity, a sample from a person who is not pregnant may be reported as positive.

The manufacturer is updating the package insert in response. The updated insert will state that low HCG levels can occur at or after the onset of perimenopause. Health Canada says customers should keep this in mind when interpreting results from the cassettes.

The notice does not describe any injuries or adverse events. It also does not say how the issue was identified.

Who Should Be Concerned

The recall is aimed at healthcare audiences, meaning the professionals and facilities that use these cassettes to test samples. The notice does not name provinces or retailers. The company is based in Ottawa, and the recall is published through Health Canada’s recalls and safety alerts system.

Anyone who has relied on a positive result from one of these cassettes, particularly for a person in or approaching perimenopause, should keep the performance issue in mind. Because the affected products cover all lots, users cannot rule out the issue by checking a lot number.

What Consumers Need to Do Now

The only action Health Canada lists is to contact the manufacturer if additional information is required. The notice does not tell users to stop using the cassettes, and it does not mention a refund, replacement or return process.

• Check whether your facility uses hCG Combo Cassette 25 (92225CA) or hCG Cassette 25 (92217CA).
• Read the updated package insert once it is available, including the new note on perimenopause.
• Take the possibility of a false positive into account when interpreting results from non-pregnant individuals.
• Contact Abbott Rapid Diagnostics ULC, 185 Corkstown Road, Ottawa, Ontario, K2H 8V4, for further information.

Health Canada also invites the public to report a health or safety concern through its reporting page. It offers email alerts for new and updated recall notices.

Regulatory Response

Health Canada published the notice as a health product recall and assigned it to Type II. The notice carries an original published date of October 2, 2026, and a last updated date of the same day. The agency states that the package insert is being updated and that customers should consider the information when interpreting results.

Health Canada has not announced a removal of the products from the market. As of the notice, the main change is the revised package insert and the guidance on interpreting results.

Why This Matters for Test Users

A false positive on an hCG test can lead to confusion, repeat testing or follow-up that is not needed. For that reason, the performance note on low HCG levels, which can occur at or after the onset of perimenopause, is worth sharing with anyone who reads or acts on these results. Staff who interpret the cassettes should be aware that a positive result in a non-pregnant individual may reflect the issue described in the notice.

Readers who want the full details can consult the original Health Canada notice for recall RA-82719. Updates, if any, will be posted on the same page.