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Advia Centaur Systems
- Starting date:
- November 8, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16303
Recalled Products
- Advia Centaur System - HBc Total Assay
- Advia Centaur XP System - HBc Total Assay
- Advia Centaur CP System - HBc Total Assay
Reason
Siemens has received complaints regarding a perceived increased rate of reactive results with specific Advair Centaur HBCT Assay kit lots, that do not correspond with other HBV Serological Markers. HBCT Readypack lot numbers ending in 044, 045, and 046 do not meet the specificity claims in the IFU. Product code 07566733 is used with the Advia Centaur, Advia Centaur XP, and Advia Centaur CP systems.
Affected products
A. Advia Centaur System - HBC Total Assay
Lot or serial number
84160044, 84249044, 84631044, 84871044, 86097045, 86415045, 86464045, 87448046, 87929046
Model or catalog number
07566733
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
B. Advia Centaur XP System - HBC Total Assay
Lot or serial number
84160044, 84249044, 84631044, 84871044, 86097045, 86415045, 86464045, 87448046, 87929046
Model or catalog number
07566733
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
C. Advia Centaur CP System - HBC Total Assay
Lot or serial number
84160044, 84249044, 84631044, 84871044, 86097045, 86415045, 86464045, 87448046, 87929046
Model or catalog number
07566733
Companies
- Manufacturer
- Siemens Healthcare Diagnostics Inc.