Reported Jan 21, 2015 · Terminated

MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This…

Biocare Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocare Medical Llc · 4040 Pike Ln · Concord, CA · 94520-1227

- MUM-1 (Multiple myeloma oncogene-1)
- catalog number PRM352 AA
Product UsageFor In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub
classification of lymphoid malignanciesMultiple 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

Lot codes and dates: Lot 061013
Exp 2016/06
Lot 073013
Exp. 2016/07
Lot 071614
Exp. 2017/07
Amount recalled: 59

Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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