Events

Recall of ACCESS SYSTEM ACCESS 2 ANALYZER - CLASS 2

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
    21465
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-01
  • 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
    Potential problem with the 10-tooth (10t) and 14-tooth (14t) mixer pulley assemblies in the access family of immunoassay systems. it has been determined that in some cases pulley drive components have broken parts or have become loose mis-positioned or disconnected from their drive. when these defects occur the pulley might not turn at all or may turn at an incorrect speed resulting in inadequate mixing of the contents of the reaction vessel which can lead to erroneous test results.

Device

ACCESS SYSTEM ACCESS 2 ANALYZER - CLASS 2
  • Model / Serial
    Model Catalog: 81600N (Lot serial: > 10 numbers contact mfg); Model Catalog: 386220 (Lot serial: > 10 numbers contact mfg); Model Catalog: A25640 (Lot serial: > 10 numbers contact mfg); Model Catalog: 4767 (Lot serial: > 10 numbers contact mfg); Model Catalog: A15642 (Lot serial: > 10 numbers contact mfg); Model Catalog: 476501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 81600 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    ACCESS 2 IMMUNOASSAY SYSTEM PART NUMBERS 81600N 386220
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.