Events

Recall of Device Recall Glypican3 (1G12 Mab) CM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Leica Biosystems Richmond 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
    78055
  • Event Risk Class
    Class 2
  • Event Number
    Z-3121-2017
  • Event Initiated Date
    2017-07-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158568
  • 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
    A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
  • Action
    Advance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000.

Device

Device Recall Glypican3 (1G12 Mab) CM
  • Model / Serial
    Product Code PA0800, Lot No. 46232, Exp. Date 06/04/2019
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
  • Product Description
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.
  • Manufacturer
    Leica Biosystems Richmond Inc.

Manufacturer

Leica Biosystems Richmond Inc.
  • Manufacturer Address
    Leica Biosystems Richmond Inc., 5205 Route 12, Richmond IL 60071
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA