BD observed an increasing trend of complaints for unusual staining pattern, nonspecific aggregates, high background, double positive signal, and/or antibodies contaminated with substance for the affected catalog. The investigation detected a damaged component in affected product catalog may affect integrity of stained cells, causing increase in cell debris (i.e. background) as shown on SSC VS CD45 positive leukocyte flow cytometry plots, resulting in atypical increase of double positive events on CD3+CD4+ vs CD3+CD8+ and/or CD3-CD16+CD56+ vs CD3-CD19+ plots. Recall start date: May 8, 2024
RecallTracker