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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 Beckman Coulter Australia Pty Ltd
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