ADVIA Centaur CP System - Procalcitionin (PCT) Assay and ADVIA Centaur System - Procalcitionin (PCT) Assay (2018-02-13)

Starting date:

February 13, 2018

Posting date:

March 2, 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-66076

• 
  Reason
• 
  Affected products

Affected products

A. ADVIA CENTAUR CP SYSTEM - PROCALCITONIN (PCT) ASSAY

B. ADVIA CENTAUR SYSTEM - PROCALCITONIN (PCT) ASSAY

Reason

Siemens Healthcare Diagnostics has received multiple customer complaints for invalid calibrations with ADVIA centaur systems B·R·A·H·M·S Procalcitonin reagent kits. This issue affects the ADVIA Centaur/XP/XPT and ADVIA Centaur CP Systems. The 'calibrator ratio' parameter may fall below the acceptable range resulting in an invalid calibration preventing customers from generating procalcitonin results.

Affected products