Events

Recall of ACCESS IMMUNOASSAY SYSTEM - TROPONIN ASSAY

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
    41786
  • Event Risk Class
    III
  • Event Initiated Date
    2011-12-22
  • 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
    Internal testing has shown that a sample containing 10.37 ng/ml of troponin i had a calculated concentration of 8.0 ng/ml when diluted and also that samples above this concentration would have lower than expected recoveries when diluted. if dilution recovery tests are run results might not match dilution recovery data provided in the instructions for use (ifu).

Device

ACCESS IMMUNOASSAY SYSTEM - TROPONIN ASSAY
  • Model / Serial
    Model Catalog: A78803 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 33340 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ACCESS IMMUNOASSAY SYSTEM ACCESS ACCUTNL REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.