Events

Recall of Device Recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Microsystems, Inc..

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
    73823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1704-2016
  • Event Initiated Date
    2016-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145056
  • 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
    Novocastra liquid mouse monoclonal antibody calretinin when used in combination with specific lots of antibody diluent will give reduced staining.
  • Action
    A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; LMGRA@leica-microsystems.com

Device

Device Recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin
  • Model / Serial
    Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
  • Product Description
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. || Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Manufacturer Address
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA