Events

Recall of COULTER ACT TAINER REAGENT 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
    56053
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-25
  • 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
    Bekcman coulter has received an increased number of service calls and customer complaints related to the hemoglobin (hgb) parameter on the act series analyzers. an investigation revealed that the issues may have been related to variability in a component of the diluents which in turn may lead to a film coating the inside of the wbc bath where the hgb is measured. the issue is not observed with all analyzers.

Device

COULTER ACT TAINER REAGENT KIT
  • Model / Serial
    Model Catalog: 8547135 (Lot serial: 113074K - 113088K); Model Catalog: 8547111 (Lot serial: 113074K - 113088K); Model Catalog: 8547110 (Lot serial: 112077K - 112096K); Model Catalog: 8547134 (Lot serial: 112077K - 112096K)
  • Product Description
    COULTER ACT TAINER REAGENT KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.