Recall Z-0965-2015— Biocare Medical Llc

Class II FDA medical device recall by Biocare Medical Llc, initiated 2014-12-12, terminated 2015-03-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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

Classification

Class II

Status

Terminated

Initiated

2014-12-12

Terminated

2015-03-30

Firm location

Concord, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.