Official recall record
Atellica CI System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Siemens Healthineers has confirmed through the internal investigation of customer complaints that the IMT diluent volume remaining (% remaining) does not decrease as expected on the Atellica® CI analyzer. The IMT module runs a standard a refresh sequence before processing samples if at least two minutes of inactivity have passed. IMT diluent is used by this sequence, however, the calculated diluent volume is not accurate, potentially leading to the IMT diluent being empty while still displaying that volume is remaining. In this case sodium (Na), potassium (K) and chloride (Cl) test results may be falsely elevated. quality control materials demonstrate the same behavior. Recall start date: November 6, 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.
Record last checked against the registry on 2026-05-31.