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Advia Centaur, Advia Centaur CP, Advia Centaur XP Systems (2013-12-20)
- Starting date:
- December 20, 2013
- Posting date:
- March 20, 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-38437
Recalled Products
A. Advia Centaur CP system - LH Assay
B. Advia Centaur XP system - LH Assay
C. Advia Centaur system - LH assay
Reason
Through internal investigation, Siemens has determined that the analytical sensitivity of the Advia centaur LH assay may vary from 0.07 MIU/mL as described in the instructions for use (IFU). internal studies indicate that customers may observe a variance of up to 0.12 MIU/mL from the IFU value of 0.07 MIU/mL.
Affected products
A. Advia Centaur CP system - LH Assay
Lot or serial number
01756298
02212941
Model or catalog number
All lots
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Centaur XP system - LH Assay
Lot or serial number
01756298
02212941
Model or catalog number
All lots
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C. Advia Centaur system - LH assay
Lot or serial number
01756298
02212941
Model or catalog number
All lots
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES