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.
FDA Recall Z-0965-2015 · Posted 2015-01-13
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Recalling FirmBiocare Medical Llc
Recall StatusTerminated
Product CodeNJT
Date Initiated2014-12-12
Date Terminated2015-03-30
Product Quantity59
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.
Firm Action
Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues
800-799-9499.
Root Cause
Incorrect or no expiration date
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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