Atellica CH A-LYTE Integrated Multisensor (2019-04-07)

Starting date:

April 7, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69728

Last updated: 2019-04-30

• 
  Reason
• 
  Affected products

Affected Products

Atellica CH A-LYTE Integrated Multisensor

Reason

Siemens Healthcare Diagnostics has confirmed that the A-Lyte Integrated Multisensor (IMT Na K Cl) may not routinely meet the instructions for use (IFU) onboard stability claim of 14 days or 5000 tests. Customers may observe a failure to calibrate during the expected use life of the sensor due to chloride slope out of acceptable range failures or potassium drift errors.

Affected products