Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - NA+ SLIDES (SODIUM)

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
    98760
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-23
  • 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
    Ortho clinical diagnostics (ortho) identified the potential for biased results to be generated over the 10 day on-analyzer storage limit when using vitrosna+ slide cartridges warmed between 1.5 to 8 hours then placed on the analyzer. ortho has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - NA+ SLIDES (SODIUM)
  • Model / Serial
    Model Catalog: 837 9034 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS Chemistry Products Na+ Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS