Events

Recall of S-CAL CALIBRATOR KIT

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
    68281
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-05
  • 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 calibration criteria tables are missing from the s-cal calibrator kit instructions for use (ifu). the ifu refers the customers to the product manuals and/or online help. the product manual for the act 8/10 does not contain the calibration criteria table.

Device

S-CAL CALIBRATOR KIT
  • Model / Serial
    Model Catalog: 179310 (Lot serial: ALL); Model Catalog: 624519 (Lot serial: RELEASED AFTER DECEMBER 2009); Model Catalog: 179310 (Lot serial: RELEASED AFTER DECEMBER 2009); Model Catalog: 624519 (Lot serial: ALL)
  • Product Description
    S-CAL CALIBRATOR KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.