| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01204-1 |
| Product Name/Description |
Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD)
Unicel DxH 800 Coulter Cellular Analysis System
Reference Numbers: 629029, B24465 and B24802
Software version: 3.0.2.0
Unicel DxH SMS Coulter Cellular Analysis System
Reference Numbers: 775222
Software version: 3.0.2.0
Unicel DxH 600 Coulter Cellular Analysis System
Reference Numbers: B23858
Software version: 1.1.1.0
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
During internal testing, it was determined that the software for various DxH systems allows for the creation of multiple orders with the same specimen identification (ID), but a different patient identification when manually editing pending orders at the System Manager.
This issue does not occur for edits of released results or for test orders requested through host transmission.
There is a possibility of sample misidentification and the release of erroneous results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users not to edit the Specimen ID for a pending test order at the System Manager's Worklist. A software upgrade will be available to correct the issue. This action has been closed out on 13 Jun 2017. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |