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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00056-1
Product Name/Description	A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (IVD) Part number A52101 serial numbers earlier than AU50137 are affected Part number A52102 serial numbers earlier than AU50014 are affected Part number A52103 serial numbers earlier than AU45311 are affected
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/01/2013
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has identified an internal wiring problem in certain Navios Reagent Carts that may result in a severe shock hazard and instrument failure or shut down. During manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. Normal vibration of the compressor frame could wear through the wiring's shielding and insulation material and connect electrical current to the Reagent Cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard.
Recall Action	Recall for Product Correction
Recall Action Instructions	If the compressor fails or the system shuts down unexpectedly, unplug the laboratory power source and call Beckman Coulter Customer Service. A Beckman Coulter service engineer will be contacting the affected customers to arrange for an inspection of the device and make all necessary corrections if an issue exists with the wiring within the compressor module.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre