Events

Recall of APO CAL (APOLIPOPROTEIN 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
    47527
  • Event Risk Class
    III
  • Event Initiated Date
    2010-02-17
  • 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 determined upward shift in patient and control recovery with synchron systems apolipoprotein b (apob) reagent lots m908383 and higher when used with apolipoprotein calibrator (apo cal) lots m901536 and m904505.

Device

APO CAL (APOLIPOPROTEIN CALIBRATOR)
  • Model / Serial
    Model Catalog: 469170 (Lot serial: M904505); Model Catalog: 469170 (Lot serial: M901536); Model Catalog: 467905 (Lot serial: M908768); Model Catalog: 467905 (Lot serial: M908383)
  • Product Description
    APO CAL (APOLIPOPROTEIN CALIBRATOR)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.