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Health Canada Medical devices

Atellica CI System

Issued November 15, 2024
Issue
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
Hazard description
Performance
Product
Product name
Atellica CI System
Reference
ID
RA-76514