Events

Safety Alert for Automated Haematology Analyser

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Sysmex Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-16
  • Event Date Posted
    2013-10-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131016e.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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.

Device

Automated Haematology Analyser
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sysmex Automated Haematology Analyser
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation