| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00286-1 |
| Product Name/Description |
ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). An in vitro diagnostic medical device (IVD)
ORTHO VISION Analyser for ORTHO BioVue Cassettes
Software Versions: 2.12.6 and below
Product Code: 6904579
ORTHO VISION Max Analyser for ORTHO BioVue Cassettes
Software Versions: 2.12.10
Product Code: 6904578
ARTG Number: 229946
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics is issuing this notice due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a Reagents Load/Unload request.
If an unexpected change is made in a LOAD STATION location that was not selected via the Graphical User Interface (GUI), the system will not detect the change. If users deviate from normal process for changing patient samples, these can be associated with another Sample ID, potentially leading to erroneous test results. In the unlikely event the error occurred, it may lead to an incorrect Rh(D) or incorrect cross matching result. There have been no reports of patient injury.
Update: Ortho has advised an additional unlikely scenario where it is also possible for a user to unexpectedly remove or interchange diluents in a location that was not selected on the Graphical User Interface (GUI) after making a Reagents Load/Unload request. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics is advising users to ensure samples, diluents and dilution trays are loaded and unloaded using the Graphical User Interface (GUI). The issue will be addressed in a future software version. Any concerns regarding previously generated results should be discussed with the Laboratory Director. This action has been closed-out on 02/02/2017. |
| Contact Information |
1800 032 359 - OCD Technical Solutions Centre |