IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2012-RN-01215-1

Class I

2012-11-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01215-1

There have been reports of results not being interpreted in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software doesn't include the reaction of this well when sending the result to the laboratory host (result code-30).This can occur in the following situations;1. ih-com software is connected to the laboratory host through astm communication mode, and2. an "abo not interpretable" result is obtained due to a reaction "?" or "+-" or "dp" in the anti-ab well of the id-card intended for abo forward grouping, and3. the "second reading" option is deactivated and ih-com results are directly sent to the host, or4. the "second reading" option is activated by the the "not interpretable" result is obtained in ih-com directly saved and sent to host without a manual selection by the user in abo scrollbar.

Bio-Rad Laboratories will be providing work around instructions in the customer letter. A software update will be implemented to correct the problem.