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U.S. Department of Health and Human Services

Class 2 Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody

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  Class 2 Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody see related information
Date Initiated by Firm December 12, 2014
Date Posted January 13, 2015
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-0965-2015
Recall Event ID 70010
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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.
Code Information Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
Recalling Firm/
Biocare Medical Llc
4040 Pike Ln
Concord CA 94520-1227
For Additional Information Contact Scott Huntsman
Manufacturer 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.
FDA Determined
Cause 2
Incorrect or no expiration date
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.