| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01255-1 |
| Product Name/Description |
AU5800 Clinical Chemistry Analyzer, software versions 4.05 and prior. An in vitro diagnostic medical device (IVD)
All serial numbers affected
All software versions 4.05 and prior are affected.
An in vitro diagnostic medical device |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is providing updated work instructions to mitigate the issue. A software update will be implemented as a permanent solution. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |