Events

Recall of GASTROCCULT TEST KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    30381
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-02
  • 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
    Beckman coulter has confirmed an issue where the ph test area for the gastroccult kit may display an unexpected color for a sample at a ph 7 reading when compared to the associated section of the color comparator bar. a sample with a ph 7 may exhibit a brownish-yellow color reading instead of the expected olive green color. the issue was first reported by a us account in march 2015 but the issue was escalated due to trending observed in january 2016.

Device

GASTROCCULT TEST KIT
  • Model / Serial
    Model Catalog: 66040 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    GASTROCCULT 40T
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.