Events

Recall of Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cell Marque Corporation.

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
    59436
  • Event Risk Class
    Class 3
  • Event Number
    Z-3110-2011
  • Event Initiated Date
    2011-07-12
  • Event Date Posted
    2011-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102783
  • 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
    Incorrect label on product bottle, although labeling on outer box is correct.
  • Action
    The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.

Device

Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.
  • Model / Serial
    Lot Number 1113202A, Exp date: 2014-04.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
  • Product Description
    Cell Marque antibody CD99 (H036-1.1) || Mouse Monoclonal Antibody. || Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 || The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Manufacturer Address
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677
  • Manufacturer Parent Company (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA