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Advia Centaur, Advia Centaur CP and XP System (2014-09-29)

Starting date:
September 29, 2014
Posting date:
October 9, 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-41721

Recalled Products

A) Advia Centaur CP System- Calibrator E
B) Advia Centaur XP System - Calibrator E
C) Advia Centaur System - Calibrator E

Reason

Calibrator e is used for calibration of the Advia Centaur Systems Cortisol, Progesterone and Testosterone assays. Siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the Advia Centaur Systems Cortisol and Progesterone Assays compared to the respective master curves. Patient serum samples evaluated with the Advia Centaur Cortisol Assay and calibrated with calibrator E kit lots listed in table 1 demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. Patient serum samples evaluated with the Advia Centaur Systems Progesterone Assay and calibrated with calibrator E kit lots ending in 38 and 39 demonstrate a positive bias with samples above 30 ng/ml. The average positive bias on the Advia Centaur/Advia Centaur XP is 20% with a maximum bias of 39%. The average positive bias on the Advia Centaur CP is 17% with a maximum bias of 35%. The Advia Centaur Systems Testosterone Assay is not affected by this correction.

Affected products

A) Advia Centaur CP System- Calibrator E

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

04634452

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

B) Advia Centaur XP System - Calibrator E
 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

04634762
 

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES

C) Advia Centaur System - Calibrator E

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

04636889

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave.
Tarrytown
10591
New York
UNITED STATES