Health Canada — Medical Devices · Canada · 2015-10-14 · Type III
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Reported risk: Beckman Coulter has received an increased number of complaints related to the hemoglobin (Hgb) parameter on the Coulter LH 500 and Coulter HmX Hematology Systems. The investigation has revealed that the issues may be related to variability in a component of the Coulter ISOTON III and Coulter LH Series diluent reagents which in turn may lead to a film coating the inside of the white blood cell (WBC) bath where Hgb is measured. The use of the affected diluent lots may result in symptoms including: Failures in Hgb background at startup or during a background cycle Increases in incomplete computations (...) for Hgb
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