Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    44722
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-04
  • 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 a downward drift/shift in quality control results or low quality control results when using vitros chemistry products cocm reagent. this drift/shift will likely be observed within approximately 3-14 days of calibration. patient results may be affected in the same manner. our investigation has shown that recalibration will be initially effective in resolving the issue but that increased calibration frequency may no longer be effective over time. ocd internal testing has confirmed that this issue occurs will all lots of vitros cocm reagent that are within expiration dating. as a result customers are being asked to discontinue using and discard all vitros cocm reagent remaining in their inventory.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY
  • Model / Serial
    Model Catalog: 680 1995 (Lot serial: 1525-10-2901); Model Catalog: 680 1995 (Lot serial: 1525-09-2754); Model Catalog: 680 1995 (Lot serial: 1525-10-3062)
  • Product Description
    VITROS Chemistry Products COCM Reagent
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS