Access system recalls

Starting date:

November 1, 2012

Posting date:

November 26, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15915

• Reason
• Affected products

Recalled Products

1. Access Immunoassay System
2. Unicel DXC 600I Synchron Access Clinical System
3. Access Immunoassay System Part Number 81600
4. Access 2 Immunoassay System 
5. Access 2 Immunoassay System  Part Numbers 81600N, 386220
6. Synchron LXI 725 Clinical System

Reason

Potential problem with the 10-Tooth (10T) and 14-Tooth (14T) Mixer Pulley Assemblies in the access family of Immunoassay systems. It has been determined that in some cases, pulley drive components have broken parts or have become loose, mis-positioned, or disconnected from their drive. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate mixing of the contents of the reaction vessel which can lead to erroneous test results.

Affected products