Official recall record
Fetalscreen II
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-08-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
A customer complaint investigation has confirmed that the lot of Fetalscreen II stated above shows unexpected macroscopic reactivity (agglutination) when performing QC testing with the positive control cells. This will impact the reading of rosettes to validate the positive control and may impact the reading of positive tests, potentially resulting in false negative results. Recall Start Date: July 22, 2024
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 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.