Events

Safety Alert for Fully Automated Blood Coagulation Analyzer

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
    2013-11-20
  • Event Date Posted
    2013-11-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131120.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 fully automated blood coagulation analyzer the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) has posted a medical device safety alert concerning fully automated blood coagulation analyzer [model no.: cs-2000i & cs-2100i; software versions: 01-57, 01-60, 01-63], manufactured by sysmex corporation. the manufacturer is informing users about a software bug which has occurred recently concerning fully automated blood coagulation analyzer cs-2000i/cs-2100i. under certain circumstances, measurement results could be assigned to a wrong sample. when the operator registers an order for micro mode and tries to modify the order by pushing the button in the order screen or the job list screen, there is a risk of a mismatch between results and sample id numbers. the problem concerns qc as well as sample measurements which are measured in normal-mode. this problem occurs even if no modification of the sample order has been done. pushing the button already triggers the error which is caused by a possible wrong feed forward of the sample rack. the affected users should take a precaution by carry out the following instructions until the software update is available:- once an order is set for micro mode measurement, do not press the button neither in the order screen nor in the job list screen. if user would like to change the order, he/she should delete the original micro mode order first on the job list screen and then register a new order. the software bug will be fixed with a software update that is expected to be released in the first quarter of 2014. the manufacturer does not recommend a look back of previously generated results since the coagulation status changes over the time, and does recommend that this communication is reviewed with the laboratory medical director. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con334789 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 november 2013.

Device

Fully Automated Blood Coagulation Analyzer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sysmex Fully Automated Blood Coagulation Analyzer
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation