BECKMAN COULTER INC
UNICEL DXH 600 · General Hospital
Recalls (6)
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.
Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
MAUDE Adverse Events (2)
FDA Classification (66)
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital
General Hospital