FDA Device

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645

Hazard

Incorrect Hemoglobin result can be reported with software version 2A and higher.

What You Should Do

Remedy

Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.

Products

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645
Brand
Beckman Coulter Inc
UPC
All instruments with version 2A or higher.

Units Affected

234