Official recall record
VITROS® Systems (ref 75059)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Issue #1 - QC baseline statistics are not updating as expected. This only affects VITROS® Systems running VITROS® system software version 3.8.1. Issue #2 - Configurable westgard rules are not being applied as expected. This affects VITROS® Systems running VITROS® System software versions 3.8.0 and 3.8.1. Recall start date: January 31, 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.