Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00485-1
Product Name/Description enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems (an in vitro diagnostic medical device (IVD))

Multiple affected bypass modules (product codes)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/04/2014
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue Ortho Clinical Diagnostics (OCD) determined that, due to a software timing issue, a sample tube carrier being released in the Bypass Module may not be detected, potentially resulting in the next sample to be metered not advancing for processing. No error message will be posted if this occurs. The Bypass Module will stop processing samples indefinitely until an operator detects the issue and intervenes.
Recall Action Recall for Product Correction
Recall Action Instructions Ortho-Clinical Diagnostics will provide a resolution for this issue in a future software version. In the interim, end users are requested to routinely monitor the Bypass module for stoppage due to the software timing issue. This action has been close-out on 11/02/2016.
Contact Information 1800 032 359 - Ortho-Clinical Customer Technical Services