It has come to our attention that medical device manufacturer, BioRad, has initiated a field safety corrective action concerning IH-Com kit Full version (Data Management and Result Interpretation Software), with product reference 009000. The affected software versions are 03.0.43 / 03.0.52 / 03.0.59.
According to the manufacturer, in case of not interpretable results in the anti-AB well (ABO3) of ID-Cards intended for ABO forward grouping, the IH-Com software does not include the reaction of this well (result code -30) when sending the results to the laboratory Host. The issue can only occur if some specific conditions are met.
The described issue could lead to the interpretation of the ABO group only based on the results of the anti-A and anti-B wells without taking into account the result of the anti-AB well of the concerned ID-Cards.
The analysis of this issue led to the conclusion that a residual risk exists for newborns for whom ABO group is only determined through ABC forward grouping (no reverse grouping performed). In the worst case scenario, a mixed field result ("dp") in the anti-AB well in addition to a non detectable mixed field in the other wells (anti-A or anti-B), could lead to assigning a wrong ABC group to the newborn based on the mother's group.
The manufacturer advises users to immediately implement protective measures as follows:
According to BioRad, this issue will be permanently corrected through the deployment of the next IH-Com software version.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 12 December 2012