Recall MonitorHealth Products
hCG One Step Pregnancy Tests
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: hCG One Step Pregnancy Tests
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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
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.