| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00277-1 |
| Product Name/Description |
AU5800 Clinical Chemistry Analyser; all instrument serial numbers with software version 4.11 and prior (An in vitro diagnostic medical device (IVD))
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
A software error has been identified that has the potential to cause the reporting of erroneous patient results due to mis-identification by the AU5800 system.
This issue only occurs if all the following conditions apply:
a) the system is in "MEASURE 1" mode during analysis (Sequential, Barcode or Rack number mode)
b) a manual batch requisition is initiated
c) LIS is running in real time for TRI (TEST REQUESTING INFORMATION) Receive
d) when events b and c (above) occur simultaneously |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised of work around procedures to ensure erroneous results are not reported. Beckman Coulter will be addressing this issue in a future software update. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |