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Advia Centaur, Centaur CP, and Centaur XP (2013-12-30)
- Starting date:
- December 30, 2013
- Posting date:
- February 10, 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-37839
Recalled Products
A. Advia Centaur XP
B. Advia Centaur
C. Advia Centaur CP
Reason
Siemens has received and confirmed complaints of elevated cortisol calibration slopes that are outside of the defined reagent lot specific calibration slopes when using cortisol reagents prior to the end of the reagent shelf life. When this occurs, the system will flag the failed calibration of the assay, and quality control and patient results can not be generated.
Affected products
A. Advia Centaur XP
Lot or serial number
All lots
Model or catalog number
04610049
04610138
04611509
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Centaur
Lot or serial number
All lots
Model or catalog number
04610049
04610138
04611509
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C. Advia Centaur CP
Lot or serial number
All lots
Model or catalog number
04610049
04610138
04611509
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES