Events

Recall of PD-L1 IHC 22C3 PHARMDX

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGILENT TECHNOLOGIES CANADA 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
    31861
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Two complaints have been received (sr3202151 and sr3227137) from two different laboratories concerning the missing information in the ifu (instructions for use). the missing information concerns the drying step before deparaffinization where the ihc (immunohistochemistry) slides must be dried in an oven for 1 hour at a specific temperature.

Device

PD-L1 IHC 22C3 PHARMDX
  • Model / Serial
    Model Catalog: SK006 (Lot serial: 10115275B)
  • Product Description
    PO-L1 IHC 22C3 PhARMDX;PD-L1 IHC 22C3 PHARMDX
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.