This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Various Advia Centaur System (2014-10-15)
- Starting date:
- October 15, 2014
- Posting date:
- October 22, 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-41847
Recalled Products
A) Advia Centaur System (Class 3)
B) Advia Centaur XP System (Class 2)
C) Advia Centaur XP System (Class 4)
D) Advia Centaur XP System (Class 3)
E) Advia Centaur System (Class 2)
F) Advia Centaur System (Class 4)
Reason
Siemens is conducting a field corrective action for the Advia Centaur and Advia Centaur XP immunoassay systems, fluid reservoir connector tubing. The tubing for the wash 1, acid, and base bottle reservoirs may be affected. On some systems a slight cracking of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress and may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. The drip will cause the reservoir to empty faster than the system expects.
Affected products
A) Advia Centaur System (Class 3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04911855
078-A001-14
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
B) Advia Centaur XP System (Class 2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
078-A010-07
09066916
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
C) Advia Centaur XP System (Class 4)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
078-A010-07
09066916
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
D) Advia Centaur XP System (Class 3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
078-A010-07
09066916
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
E) Advia Centaur System (Class 2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04911855
078-A001-14
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES
F) Advia Centaur System (Class 4)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04911855
078-A001-14
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES