Events

Recall of CHOLESTEROL ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SEKISUI DIAGNOSTICS P.E.I. 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
    23499
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-10
  • 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
    Genzyme diagnostics has determined that there was a label error for the cholesterol assay kit. the labels on the kit components for lot 37772 were reversed. colour reagent (r1) label was on the phenol reagent and phenol reagent (r2) label was on the colour reagent. label error will not affect test results as long as components of this lot are not interchanged with components from other lots.

Device

CHOLESTEROL ASSAY
  • Model / Serial
    Model Catalog: 225-26 (Lot serial: lot 37772)
  • Product Description
    Cholesterol Assay Cat No.225-26
  • Manufacturer
    SEKISUI DIAGNOSTICS P.E.I. INC.

Manufacturer

SEKISUI DIAGNOSTICS P.E.I. INC.