AUTOMATE 2500 SYSTEM (2014-10-10)

Starting date:

October 10, 2014

Posting date:

June 26, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Identification number:

RA-53926

• Reason
• Affected products

Recalled Product

A.AUTOMATE 2500 SYSTEM
 

Reason

An IR sensor module failure can occur and can be identified by one of the following: volume detection error message ErrID: 5694, timeout error message ErrID: 5405, system initialization failure of the conveyor belt module. Immediately prior to the failure there is a remote possibility that the IR sensor module may not properly detect the sample volume in the tube. The IR sensor module is part of the Tube Inspection Unit (TIU) and is responsible for sample volume detection on AutoMate systems. Failure to properly detect the sample volume in the tube may cause an increased number of primary and secondary sample tubes to be transferred to the error workplace on the AutoMate system. As a result of the failure, there may be unexpected downtime of the AutoMate system.

Affected products