CanadaWhat's being recalled
Companies: Innovacon, Inc., 9942 Mesa Rim Road, San Diego, California, United States, 92121.
How to identify it
Affected products: hCG One Step Pregnancy Test Device (Urine/Serum); Lot or serial number: All lots.; Model or catalogue number: FHC-202
Affected products: hCG One Step Pregnancy Test Strip (Urine); Lot or serial number: All lots.; Model or catalogue number: FHC-101
The 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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)