Alerta De Seguridad para Automated Haematology Analyser

Safety alert

2013-10-16

2013-10-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016e.html

Medical device safety alert: sysmex automated haematology analyser the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) has posted a field safety notice concerning automated haematology analyser [model no: xn-10 & xn-20; serial no.: all], manufactured by sysmex corporation. the manufacturer was informed from the uk market that in very rare cases falsely high haemoglobin (hb) values may occur, creating the potential risk of missed transfusions for patients with low hb values. as this does not occur in samples which were mixed correctly, the manufacturer deduces that correct pre-analytical procedures and mixing can prevent this phenomenon. in studies performed on the xn-series analysers, the manufacturer has confirmed that the mixing function is effective for healthy volunteer samples which are measured less than 4 hours after the blood has been collected. however, for other samples with high viscosity or erythrocyte sedimentation rates (e.G. polymyalgia rheumatica, temporal arteritis or malignant lymphoma) or samples stored in the refrigerator, there is the possibility that the instruments standard mixing cycle may not be sufficient to suitably mix the sample. affected users are reminded to always ensure that samples are mixed sufficiently before being placed on the analyser, especially for samples from patients prone to high degrees of sedimentation or for cooled samples. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 october 2013.