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Biocare Medical Llc recalls MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This ant
Recalled January 21, 2015 · FDA recall Z-0965-2015 · Biocare Medical
Hazard
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed. · FDA Class II
Units
59
Sold at
Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
Description
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Product
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone . MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
Manufacturer(s)
Biocare Medical Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →