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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