Device 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.
Z-0965-2015
Product summary
- Event
- Event 70010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59
- Official record key
device-enforcement:Z-0965-2015
Official wording
Reason: Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Code information: Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.