Health Canada2 Oct 2026
hCG One Step Pregnancy Tests
Health Canada published a recall notice for hCG One Step Pregnancy Tests on 2 Oct 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 2 Oct 2026
- Recall type
- Health product recall
- Companies
- Innovacon, Inc. · 9942 Mesa Rim Road, San Diego, California, United States, 92121
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-10-02 Affected products: Affected products Lot or serial number Model or catalogue number hCG One Step Pregnancy Test Device (Urine/Serum) All lots. FHC-202 hCG One Step Pregnancy Test Strip (Urine) All lots. FHC-101 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.