Official recall record
hCG Cassettes
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-10-15.
Record last checked against the registry on 2026-10-15.
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