Events

Recall of Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocare Medical Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0965-2015
  • Event Initiated Date
    2014-12-12
  • Event Date Posted
    2015-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132108
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Three lots of mum-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
  • Action
    Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues 800-799-9499.

Device

Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody
  • Model / Serial
    Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
  • Product Description
    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.
  • Manufacturer
    Biocare Medical Llc

Manufacturer

Biocare Medical Llc
  • Manufacturer Address
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520-1227
  • Manufacturer Parent Company (2017)
    Biocare Medical LLC
  • Source
    USFDA