Dimension Enzyme Calibrator's (2016-05-13)

Starting date:

May 13, 2016

Posting date:

May 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-58626

• Reason
• Affected products

Affected products 

A. DIMENSION VISTA SYSTEM- ENZYME CALIBRATOR

B. DIMENSION CLINICAL CHEMISTRY SYSTEM- ENZYME II CALBIBRATOR (ENZ II CAL)

C. DIMENSION XPAND SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL)

D. DIMENSION EXL SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL)

Reason

Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with specific lots of Dimension Enzyme II Calibrator. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibration lots. The shift began with lot 4MDO47.

Affected products