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Health product recall

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

  1. ADVIA CENTAUR SYSTEM - INSTRUMENT - CLASS 3
  2. ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS 2
  3. ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS II
  4. ADVIA CENTAUR SYSTEM - INSTRUMENT CLASS IV
  5. 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