ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-02-28)

Starting date:

February 28, 2018

Posting date:

March 19, 2018

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-66188

• 
  Reason
• 
  Affected products

Affected products

A. ADVIA Centaur System-Creatine Kinase-MB (CKMB) Assay

B. ADVIA Centaur CP System-Creatine Kinase-MB (CKMB) Assay

Reason

Siemens' complaint investigation has confirmed that the calibration flag "Invalid, Exceeded defined ranges" may be triggered due to the slope value exceeding the acceptable range. The resulting invalid calibration prevents customers from generating CKMB results.                                      

When valid calibrations and in range Quality Control (QC) results are obtained, patient results are valid and acceptable for reporting. When an invalid calibration is received, QC and patient testing cannot be performed.

Affected products