ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00201-1

Class I

2016-03-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00201-1

Ortho-clinical diagnostics (ortho) has identified an anomaly in ortho vision analyser software that may occur when either:1. an ocd 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 2. 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.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. no customer complaints or patient injuries have been reported due to this issue.

Ortho Clinical 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. This action has been closed-out on 20/02/2017.