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Health product recall

Advia Centaur and Advia Centaur XP Systems - Insulin Assays (2014-02-10)

Starting date:
February 10, 2014
Posting date:
March 25, 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-38553

Recalled Products

A. Advia Centaur XP System - Insulin (IRI) Assay

B. Advia Centaur System - Insulin Assay

Reason

Siemens Healthcare Diagnostics received customer feedback on the advia centaur systems insulin assay, indicating a low, but increased rate of calibration failures for the advia centaur systems insulin assay. A limited number of customers have experienced the calibration failures. This issue is not applicable to the Advia Centaur CP.

Affected products

A. Advia Centaur XP System - Insulin (IRI) Assay

 

Lot or serial number

128434

 

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave.

Tarrytown

10591

New York

UNITED STATES



B. Advia Centaur System - Insulin Assay

Lot or serial number

128434

Model or catalog number

More than 10 numbers, contact manufacturer

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave.

Tarrytown

10591

New York

UNITED STATES