The field service engineer performed troubleshooting on the unicel dxh 800 coulter cellular analysis system and observed platelet background failures with five lots of coulter dxh diluent.The instrument was monitored by the customer and the quality control samples were recovering within range.The mdr is related to the following mdrs, associated with each of the five lot numbers of coulter dxh diluent observed with this issue at this customer facility: mdr 1061932-2014-02195, mdr 1061932-2014-02196, mdr 1061932-2014-02197, mdr 1061932-2014-02198, mdr 1061932-2014-02199.
|