Medical Device Safety Alert: Ortho Clinical Diagnostics Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
The manufacturer observed an increased number of complaints related to false positive and/or reactions containing haze in the Anti-A and buffered gel micro-tubes used for reverse ABO typing in the MTS A/B/D Monoclonal and Reverse Grouping Card lots listed above. Investigation by the manufacturer determined that the false positive reactions were due to broken gel beads in the micro-tubes of the MTS cards.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to the following Health Canada website:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40629r-eng.php
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 July 2014