Immucor Inc. has indicated that this medical device recall is to communicate that some vials of indicated lot numbers 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 hemolysis and dark color. This issue is random across kits in these lots and is not present in all vials within the kit. Recall start date: June 27, 2024
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