Events

Recall of Bond ReadyToUse Primary Antibody Thyroglobulin (1D4)

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
    68079
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-2015
  • Event Initiated Date
    2014-04-18
  • Event Date Posted
    2014-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126910
  • 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
    Bond ready to use primary antibody thyroglobulin does not function as intended up to the expiry date on the product labelling. this was detected through an on-going stability program. there is a link between the age of the product and staining intensity.
  • Action
    Leica Biosystems sent a Medical Device Recall Notification letter dated April 18, 2014, to all affected customers. The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.

Device

Bond ReadyToUse Primary Antibody Thyroglobulin (1D4)
  • Model / Serial
    Product Code: PA0025; Lot Numbers and Expiration Dates: 24963, Expires 17 DEC 2014; 24228, Expires 15 OCT 2014; 23882, Expires 10 SEP 2014; 23366, Expires 23 JUL 2014
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, Turkey, and the United Kingdom.
  • Product Description
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. || This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
  • 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