| 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 |
|
| 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 |