Health product recall

Atellica CI System

Last updated

Summary

Product
Atellica CI System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Atellica CI System

IRC009062411
IRC007512342
IRC009012411

10947347

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave, Tarrytown, New York, United States, 10591
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-76514

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