ADVIA Centaur System Calibrator (2016-02-16)

Starting date:

February 16, 2016

Posting date:

March 4, 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-57398

• Reason
• Affected products

Affected Products

• A. ADVIA CENTAUR CP SYSTEM-CALIBRATOR
• B. ADVIA CENTAUR SYSTEM-CALIBRATORS

Reason

Siemens Healthcare Diagnostics has confirmed a lot to lot bias with calibrator E kit for the ADVIA Centaur Testosterone assay.
Internal investigation demonstrates: 

• an average positive bias of 17% across the assay range with calibrator E kit lots ending in 42 as compared to values generated with the master curve. 
• an average negative bias of 7% across the assay range with calibrator E kit lots ending in 43 as compared to values generated with the master curve. 
• the positive bias of calibrator E kit lots ending in 42 to the master curve compared to the negative bias of calibrator E kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator E kit lots ending in 42 and calibrator E kit lots ending in 43.

The bias of the calibrators to the master curve has been corrected with calibrator E kit lots ending in 44.

The performance of the testosterone assay on the ADVIA Centaur CP is not affected.

Calibrator E is also used for calibration of the ADVIA centaur systems cortisol and progesterone assays, however the performance of these assays is not affected.

Affected products