Events

Recall of VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II

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
    132284
  • Event Risk Class
    II
  • Event Initiated Date
    1999-12-01
  • 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
    Autodilution pump does not consistency dispense the expected amount of diluent at settings involving 180 or 190 ul dilution volumes.

Device

VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Model / Serial
    Model Catalog: 8633893 (Lot serial: all Ser. up to 30000861); Model Catalog: 8633893 (Lot serial: EXCEPT 30000861 30000775); Model Catalog: 8633893 (Lot serial: 30000838 AND 30000851)
  • Product Description
    VITROS ECI IMMUNODIAGNOSTIC SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS