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An official Health Canada notice concerns Atellica ci system. 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 Published 2024-11-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76514
Official notice
2024-11-15
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Siemens, Atellica Ci System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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