MUM-1 — Class II medical device recall Z-0965-2015
Terminated recall by Biocare Medical Llc, reported 2015-01-21, distributed nationwide. Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been
| Recall number | Z-0965-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical Llc, Concord, CA, United States |
| Recall initiated | 2014-12-12 |
| Classified | 2015-01-13 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN, KW, NZ, TR, UY, VE |
| Quantity | 59 |
| Reason classes | labeling |
| Lot numbers | 061013, 071614, 073013, 2016/06, 2016/07, 2017/07 |
| Model numbers | PRM352AA |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0965-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.