Beckman coulter became aware of this event on (b)(4) 2014 when the malfunction was assessed and determined to be reportable.On (b)(4) 2014, the beckman coulter field service engineer instructed the customer to replace dxh diluent lot number 3510490 on system with new diluent, lot number 3510460.After new diluent was primed, backgrounds passed.(b)(4).There were two unicel dxh 800 coulter cellular analysis systems in this customer's facility.Mdr 1061932-2014-02005 was associated with serial number (b)(4).This mdr is associated with serial number (b)(4).
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