Events

Recall of SYNCHRON CX MULTI CALIBRATOR

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
    98806
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-16
  • 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
    Due to a labelling error some synchron systems multi calibrator diskettes (ref 442600 lot m002642g) may actually be thyroxine (t4) reagent calibrator diskettes. this issue only impacts synchron lx and dxc systems. this issue does not impact synchron cx systems.

Device

SYNCHRON CX MULTI CALIBRATOR
  • Model / Serial
    Model Catalog: 442600 (Lot serial: M002642G); Model Catalog: (Lot serial: )
  • Product Description
    Synchron Systems Multi Calibrator Diskette
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.