Dimension EXL System (2014-07-15)

Starting date:

July 15, 2014

Posting date:

July 25, 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-40683

• Reason
• Affected products

Recalled Products

A) Dimension EXL System - Dimension EXL Analyzer with Loci Module
B) Dimension EXL System - Dimension EXL Analyzer with IM
C) Dimension EXL System - Dimension EXL 200 Analyzer

Reason

Manufacturer has confirmed that the reagent lid hinge (hinge lid (heavy) 121-187IN-LB) used on the Dimension EXL integrated chemistry systems may lose its effectiveness and slowly shift downward during maintenance procedures. The reagent lid may come in physical contact with the operator while performing routine maintenance. Patient results are not affected. The issue affects Dimension EXL with IM and Dimension EXL 200.

Affected products