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ADVIA CENTAUR SYSTEMS (2015-11-13)
- Starting date:
- November 13, 2015
- 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-56088
Affected Products
- ADVIA CENTAUR SYSTEM - INSTRUMENT - CLASS 3
- ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS 2
- ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS II
- ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV
- ADVIA CENTAUR XP INSTRUMENT
Reason
Siemens Healthcare Diagnostics is conducting a field corrective action for the ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, Glass Rod Sensor (SMN 10327638) in the waste reservoir. A potential vacuum leak may occur around the glass rod sensor in the waste reservoir, caused by the gasket on the housing of the glass rod sensor sliding out of position.
Affected products
A. ADVIA CENTAUR SYSTEM - INSTRUMENT - CLASS 3
Lot or serial number
All lots.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS 2
Lot or serial number
All lots.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
C. ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS II
Lot or serial number
All lots.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
D. ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV
Lot or serial number
All lots.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
E. ADVIA CENTAUR XP INSTRUMENT
Lot or serial number
All lots.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES