Events

Safety Alert for Lyra MP Reader II

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

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
    2015-07-23
  • Event Date Posted
    2015-07-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150723_2.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: diamed lyra mp reader ii it has come to our attention that medical device manufacturer, diamed, has issued a field safety notice concerning an automated blood grouping system - lyra mp reader ii [model number: 854002]. the manufacturer became aware that, in exceptional circumstances, the blood grouping system may incorrectly assign the results of the previously read microplate to the microplate being processed. in this specific context, the misallocated results are displayed in black and white instead of colour as would be expected. this issue could in the worst case lead to a mismatch between the test result issued and the true result of the sample. according to the manufacturer, the potential for reporting an erroneous result is very limited because the occurrence of the issue is dependent on several exceptional random factors operating together. the manufacturer advised users to use an empty microplate for balance purpose and deactivate the automatic validation of results for the system. the users should also check the colour of the results displayed before validation and should not validate the results if the images of wells appeared in black and white. as a permanent solution, the manufacturer will release a software update. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 july 2015.

Device

Lyra MP Reader II
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DiaMed Lyra MP Reader II
  • Manufacturer
    DiaMed

Manufacturer

DiaMed