Events

Recall of Device Recall Leica Microsystems Inc

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
    72802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0808-2016
  • Event Initiated Date
    2015-11-27
  • Event Date Posted
    2016-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142242
  • 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
    The firm informed the importer/distributor, leica microsystems, a manufacturing error occurred during the filling of some containers of the bond polymer refine red detection ds9390 kits, which may result in inadequate staining.
  • Action
    Leica Biosystems sent an Urgent Medical Device Recall Notice dated November 30, 2015, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Please also properly destroy any unused or partially used affected lots of the reagent, and indicate by signing and returning the attached Medical Device Recall Acknowledgement Form that this action has been undertaken. As indicated in the Instructions for Use, the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The consignees are requested to consult with their laboratory director and physician to determine whether a review of past results obtained from the affected lots is clinically warranted. Direct accounts are requested to forward the notice primarily to the end users where the product has been sold and to all those within the organization who need to be aware of this issue. Periodic effectiveness checks will be conducted to address non responders. For further questions please call ( 847) 405-5413

Device

Device Recall Leica Microsystems Inc
  • Model / Serial
    Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
  • Product Description
    Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
  • 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