Events

Recall of ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT

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
    80210
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-09
  • 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
    Four customer complaints were received for one lot of ar176 artisan grocott's methenamine silver (gms) stain kit regarding fungal looking organisms appearing after staining particularly on the periphery of slides away from the stained tissue. the contaminate was confirmed to be fungal most likely common indoor mold wallemia sebi and was confined to one reagent supplied by an outside vendor. artisan grocott's methenamine silver (gms) stain kit is indicated for identifying fungal organisms including pneumocystis jirovecii. the contamination could potentially compromise the device's diagnostic effectiveness.

Device

ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT
  • Model / Serial
    Model Catalog: AR176 (Lot serial: 10095053)
  • Product Description
    ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.