Lyra MP Reader II 의 안전성 경고

Safety alert

2015-07-23

2015-07-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150723_2.html

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.