Official recall record
Vitros® 5600, 3600 and XT Systems
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
During internal testing, QuidelOrtho™ identified that microwell assay results have the potential to be reported without the reagent expired (re) result code, even when the signal reagent (sr) pack is past the expiry date. This can occur when an sr pack exceeds the on-board expiry and/or the shelf expiration date. This issue can affect any microwell assay regardless of whether or not the system is configured to use expired reagents. Recall start date: December 24, 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.