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

• Date Initiated by Firm: December 12, 2014
• Date Posted: January 13, 2015
• Recall Status: Terminated 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/ Manufacturer: Biocare Medical Llc; 4040 Pike Ln; Concord CA 94520-1227
• For Additional Information Contact: Scott Huntsman; 925-603-8033
• 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: 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.