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Health product recall

ADVIA Centaur XPT Instrument (2016-06-21)

Starting date:
June 21, 2016
Posting date:
June 30, 2016
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-59124

Affected products

A. ADVIA Centaur XPT Instrument

Reason

Siemens Healthcare Diagnostics is issuing a customer notification for ADVIA Centaur XPT Waste Reservoir Assembly (SMN 10711091).  Siemens has determined that certain reservoirs manufactured with walls that are below the nominal specification, potentially cause cracking & leaking of seam bottom and leaking at the interface of the seam and reservoir. If leak occurs foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with low vacuum error #016001324.

Affected products

A. ADVIA Centaur XPT Instrument

Lot or serial number

IRL06591516

IRL06641516

IRL06661516

IRL06741517

IRL06971520

IRL08721541

IRL08751541

IRL08781542

IRL09631550

IRL09651550

Model or catalog number

10711433

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES