The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning IH-1000, manufactured by Bio-Rad. The affected product reference number is 001000 and all software versions are affected.
In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the IH-1000 may be observed. In these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images.
Therefore, this issue might lead to a wrong result released to the host if the 3 following conditions are met:
A result is returned as negative while the reaction is positive, Double Population, or requires a human interpretation and,
The manufacturer is providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00593-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 June 2013