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Advia Centaur and Advia Centaur XP Systems - C-Peptide (CPS) Assay (2014-03-28)
- Starting date:
- March 28, 2014
- Posting date:
- April 15, 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-39087
Recalled products
- Advia Centaur XP System - C-Peptide (CPS) Assay
- Advia Centaur System - C-Peptide Assay
Reason
Siemens Healthcare Diagnostics received customer feedback on the Advia Centaur systems C-peptide assay, indicating a low, but increased rate of Signal 2 errors. A limited number of customers have experienced the Signal 2 error codes. Patient results cannot be generated if a Signal 2 error is obtained. This issue has not been observed on the Advia Centaur CP.
Affected products
A. Advia Centaur XP System - C-Peptide (CPS) Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 03649928
- 129026
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B. Advia Centaur System - C-Peptide Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 03649928
- 129026
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES