ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-07-27)

Starting date:

July 27, 2018

Posting date:

August 17, 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-67398

• 
  Reason
• 
  Affected products

Affected products

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

Reason

Siemens Healthcare Diagnostics has identified a bias with ADVIA Centaur CKMB Calibrator Kit Lots ending in 64 (ck64) when compared to internal standards and previously released ADVIA Centaur CKMB Calibrator Kit Lots ending in 63 (ck63) on the ADVIA Centaur/XP/XPT and ADVIA Centaur CP systems.

Alignment to the internal standardization is restored with the release of ADVIA Centaur CKMB Calibrator Kit Lots ending in 68 (ck68). Customers may observe a shift in Quality Control (QC) material, Master Curve Material (MCM) and patient results when transitioning from ADVIA Centaur CKMB Calibrator Kit Lots ending in 64. Siemens has also identified the potential for out of range ADVIA Centaur CKMB Master Curve Material results when using the lot 35061on the ADVIA Centaur/XP/XPT and ADVIA Centaur CP systems.

Affected products