Events

Recall of ETHANOL - L3K ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENZYME 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
    131543
  • Event Risk Class
    II
  • Event Initiated Date
    2002-08-12
  • 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
    A contaminant in a raw material caused high background absorbance for the reagent. product could not be calibrated on a hitachi 911 instrument.

Device

ETHANOL - L3K ASSAY
  • Model / Serial
    Model Catalog: (Lot serial: 15860); Model Catalog: (Lot serial: 15859)
  • Product Description
    ETHANOL-L3K ASSAY
  • Manufacturer
    GENZYME DIAGNOSTICS P.E.I INC.

Manufacturer

GENZYME DIAGNOSTICS P.E.I INC.
  • Manufacturer Address
    CHARLOTTETOWN
  • Source
    HC