Immucor Inc. has indicated that this medical device recall is to communicate that some vials of this lot (18915) exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. It has been confirmed that there is fungal growth in the vials demonstrating dark color. This issue is random across kits in this lot and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall start date: June 12, 2024