Events

Recall of IMMAGE IMMUNOCHEMISTRY SYSTEM APB APOLIPOPROTEIN B REAGENT

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
    53158
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-09
  • 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 has confirmed the immage immunochemistry systems apolipoprotein a-1 (apa) reagent (lot number m404171) contains an important product notification insert with incomplete information. the notification references only apa lot number m401225 but should reference apa lot numbers m401225 and newer. apa lot number m404171 calibrated with apo cal lot number m305133 may produce inaccurate results (>6% low bias).

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM APB APOLIPOPROTEIN B REAGENT
  • Model / Serial
    Model Catalog: 469283 (Lot serial: M305133); Model Catalog: 446410 (Lot serial: M404171); Model Catalog: 469283 (Lot serial: M404171)
  • Product Description
    BECKMAN COULTER CLINICAL CHEMISTRY SYSTEMS APO CAL (APOLIPOPROTEIN CALIBRATOR)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.