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OFFICIAL-SOURCE RECALL · CANADA

hCG Cassettes Recall: Product may detect low levels of HCG below the

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryCanadaPublishedOctober 2, 2026Last updatedOctober 2, 2026Official source last checkedOctober 2, 2026 at 2:28 PM UTC

CHECK THE ITEM YOU OWN

Is your product affected?

Brand
See official notice
Product
hCG Cassettes
Manufacturer
See official notice

The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

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. The package insert is being updated to note that low HCG levels can occur at or after onset of perimenopause. Customers should consider this when interpreting results.

Hazard

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. The package insert is being updated to note that low HCG levels can occur at or after onset of perimenopause. Customers should consider this when interpreting results.

Official recall notice

hCG Cassettes

Agency: Health Canada

Official publication date: October 2, 2026

Read the official CANADA_MEDICAL_DEVICES recall notice →

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