Dimension Systems

Starting date:

November 28, 2011

Posting date:

January 9, 2012

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-15116

• Reason
• Affected products

Recalled products

1. Dimension Chemistry System CREA/Creatinine
2. Dimension Xpand System - Creatinine (CREA) Assay
3. Dimension EXL System - Creatinine (CREA) Assay

Reason

Siemens Healthcare diagnostics have received customer complaints regarding the potential of Dimension CREA to increase QC recovery and imprecision over time from open well. QC results shift high over time within a flex well and then recover near the QC target or expected value in a newly opened fresh well. The change in QC recovery within a flex well can be as high as 0.2mg/dl in a 24 hour period. This challenges the Dimension CREA flex open well stability claim of 5 days.

Affected products