Events

Recall of VITROS 4600 CHEMISTRY SYSTEM - HARDWARE

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
    52191
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-23
  • 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 inc. (ortho) initiated this urgent product correction notification due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the systems affected by this recall. u90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros chemistry products for immunorate assays (i.E. vitros crbm crp dgxn and phyt slides). if a u90-382 or 6lu condition code (i.E. associated with a wash error) occurs the condition code text located on the vitros system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios.

Device

VITROS 4600 CHEMISTRY SYSTEM - HARDWARE
  • Model / Serial
    Model Catalog: 680 2445 (Lot serial: >10 contact manufacturer); Model Catalog: 680 2153 (Lot serial: >10 contact manufacturer); Model Catalog: 680 1375 (Lot serial: >10 contact manufacturer); Model Catalog: 680 1759 (Lot serial: >10 contact manufacturer); Model Catalog: 813 2086 (Lot serial: >10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: >10 contact manufacturer)
  • Product Description
    VITROS 4600 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS