Events

Recall of ACCESS AMH

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
    85889
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-21
  • 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 determined that the quality control (qc) value card lists incorrect standard deviation (sd) values for the access amh qc kit lot 689202.The qc value cards for this lot list the following standard deviation values: qc1 as 0.02 qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15 qc2 is 0.76 and qc3 is 2.30.

Device

ACCESS AMH
  • Model / Serial
    Model Catalog: B13129 (Lot serial: 689202)
  • Product Description
    Access AMH QC Kit
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.