| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01011-1 |
| Product Name/Description |
AU480 Clinical Chemistry Analyser - software version 1.81
(Systems configured with Closed Channels ONLY)
Part Numbers: B12183, B11810; B71362
ARTG Number: 236636 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
A software defect has been identified on newly installed AU480 systems with software version 1.81. The defect may generate incorrect test results for 2 step method assays on AU480 systems configured with closed channels. The software defect occurs when Edit and then Confirm are pressed on the Specific Test Parameters screen of closed channels. The result is that the Measuring Point-2 settings will be deleted. The Measuring Point 2 settings are used for sample blank adjustments for 2 step methods.
For samples which may have LIH (Lipemia, Icterus, Hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Beckman Coulter FSE will visit each laboratory and change the closed channels to open channels. A set of action steps and associated instructions is also provided in the Customer Letter which Laboratories can use to determine if they have been affected. This action has been closed-out on 22/08/2016. |
| Contact Information |
1800 060 880 - Beckman Coulter |