FDA Device recall Z-0965-2015
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA by Biocare Medical, citing three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-12 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biocare Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2015%22
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