Mislabeling of elutriation medium: a demonstration of the need to improve the quality control of reagents produced for cell processing

BACKGROUND: The processing of hematopoietic cells to remove red cells, T‐lymphocytes, or malignant cells has become common. However, few of the reagents used are produced specifically for marrow processing and approved by the Food and Drug Administration. CASE REPORTS: A labeling error is reported in a commercially manufactured, research‐grade reagent used in an elutriation procedure to deplete T cells from mononuclear cells obtained from bone marrow for allogeneic transplantation. The elutriation medium used in the procedure had been labeled as containing 0.9‐percent sodium chloride, 0.1‐percent dextrose, and 0.3 mM EDTA, but it actually contained 3.0 mM EDTA. When this medium was not available from the manufacturer, it was prepared in this hospital, according to the stated formulation, with 0.3 mM EDTA. When marrows from two unrelated donors were processed with this 0.3 mM EDTA‐containing medium, cell loss due to aggregation occurred, and, in one recipient, the marrow did not engraft. After the error in the medium composition was discovered, marrow was collected a second time from the same donor. The marrow was processed with medium containing 3.0 mM EDTA, and no cell aggregation was observed. CONCLUSION: Food and Drug Administration‐approved reagents, prepared specifically for use in cell processing and produced according to good manufacturing practices, should be used whenever possible. 1995 AABB