Alerta De Seguridad para Ortho BioVue Analyser

Safety alert

2016-03-03

2016-03-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160303.html

Medical device safety alert: ortho-clinical diagnostics ortho biovue analyser the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning its ortho biovue analyser manufactured by ortho-clinical diagnostics. [ product code: 6904579 and software version: 2.12.6 and below ]. the manufacturer has identified an anomaly in ortho vision analyser software that may occur when either: the manufacturer’s field engineer performs a clean-up of the analyser database, or an operator of the vision analyser restores a database backup on the analyser, and dilution trays have not been removed from the instrument prior to restarting the system. in this scenario, the analyser software cannot identify usage history of the wells of the dilution tray on the instrument, and reuse of wells may occur. according to the manufacturer, for tests that involve dilution of patient red blood cells, the reuse of a dilution well can potentially lead to false positive or false negative results. to date, only false positive results have been observed during internal testing. there is a risk of false positive or false negative anti-d testing, which may result in haemolytic transfusion reaction. the manufacturer is reminding users to ensure the dilution wells are removed and disposed of prior to initiating a database restore operation. this issue will be addressed in a future version of the software and a technical bulletin issued to remind users to remove and dispose of dilution wells prior to restoring a database. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00201-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 march 2016.