Advia Centaur, Centaur CP, and Centaur XP Systems - Procaclitonin Assay (PCT) (2014-02-21)

Starting date:

February 21, 2014

Posting date:

April 4, 2014

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-38767

• 
  Reason
• 
  Affected products

Recalled Products

A. Advia Centaur CP System - Procaclitonin (PCT) Assay

B. Advia Centaur XP System -Procalcitonin (PCT) Assay

C. Advia Centaur System - Procalcitonin (PCT) Assay

Reason

Siemens Healthcare Diagnostics received customer feedback regarding the clinical utility of Advia Centaur Brahms Procalcitonin (PCT) quality control level 1. Quality control level 1 currently has a range of plus or minus 50% of the target. Siemens internal investigation confirmed that this range was incorrectly set. Siemens has revised the range of Advia Centaur Brahms Procalcitonin (PCT) quality control level 1 to plus or minus 30% of the target. A review of test data confirmed the assay is capable of achieving a narrower range of plus or minus 30% of the target.

Affected products