MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro D...
FDA Recall #Z-0965-2015 — Class II — December 12, 2014
Product Description
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.
Reason for Recall
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Recalling Firm
Biocare Medical Llc — Concord, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
59
Distribution
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.
Code Information
Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated