Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM -HOMOCYSTEINE (HCY) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA 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
    54589
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-04
  • 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
    Ocd has received customer complaints of lower than expected results when using lot 1529-17-2636 of vitros chemistry products hcy reagent (code 6802002). internal investigation confirmed that negatively biased results for homocysteine (hcy) could be obtained using the affected lot. as a result ocd is instructing customers to discontinue using and discard all vitros hcy reagent lot 1529-17-2636 remaining in their inventory.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM -HOMOCYSTEINE (HCY) ASSAY
  • Model / Serial
    Model Catalog: 680 2002 (Lot serial: 1529-17-2636)
  • Product Description
    VITROS Chemistry Products HCY Reagent
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.