Advia Centaur System-Calibrators

Starting date:

January 12, 2017

Posting date:

February 1, 2017

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-62060

• Reason
• Affected products

Reason

Siemens Healthcare Diagnostics has confirmed a negative bias for Advia Centaur FT4 when used with Calibrator A Kit lots ending in 90 on the Advia Centaur, Advia Centaur XP and Advia Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator relative light units (RLU) %cvs when using Calibrator A Kit lots ending in 90 with the FT4 assay.

The performance of the FT4 assay when used with Calibrator A Kit lots ending in 90 on the Advia Centaur CP System is not affected.

Customers may continue to use Calibrator A Kit lots ending in 90 for the Advia Centaur Systems FT3, T3, T4 and TUP assays.

Internal investigations were performed using available FT4 lots. The investigation confirmed an overall negative bias when comparing calibrator a kit lots ending in 90 to previously released calibrator a kit lots ending in 89.

In some instances the negative bias may cause euthyroid patient samples to result low and outside the reference interval listed in the instructions for use (IFU).
Quality control material and master curve material may result low and outside acceptable ranges.

Affected products