Advia Centaur System, XP and CP - HBC Total Assay (2014-09-17)

Starting date:

September 17, 2014

Posting date:

October 1, 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-41567

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  Reason
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  Affected products

Recalled Products

A) Advia Centaur System - HBC Total Assay

B) Advia Centaur System XP - HBC Total Assay

C) Advia Centaur System CP - HBC Total Assay

Reason

Siemens Healthcare Diagnostics has confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the Advia Centaur Systems HBC total (HBCT) assay, reagent lot 100064. The increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results

Affected products