Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0965-2015 — 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. M

U.S. FDA — Device Enforcement · United States · 2014-12-12 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0965-2015
Date of alert: 2014-12-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biocare Medical Llc
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related