Events

Recall of IMMAGE IMMUNOCHEMISTRY SYSTEMS BUF1 BUFFER 1

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER INC..

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
    42275
  • Event Risk Class
    III
  • Event Initiated Date
    2002-10-11
  • 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
    Buffer ph was unstable. qc values may be out of range.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEMS BUF1 BUFFER 1
  • Model / Serial
    Model Catalog: (Lot serial: Immage buffer lot T111211); Model Catalog: (Lot serial: Array Protein lot M204110); Model Catalog: (Lot serial: Array Protein lot M201222); Model Catalog: (Lot serial: Array Protein lot M201395); Model Catalog: (Lot serial: Array Protein lot M111205); Model Catalog: (Lot serial: Immage buffer lot T204184); Model Catalog: (Lot serial: Immage buffer lot T202211); Model Catalog: (Lot serial: Immage buffer lot T202122)
  • Product Description
    Immage Buffer and Array Buffer
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.