Events

Recall of VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

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
    114189
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-11
  • 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) has initiated this recall due to a vitros system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results. scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2413 (Lot serial: 36000264); Model Catalog: 680 2413 (Lot serial: 36000773); Model Catalog: 680 2413 (Lot serial: 36000627); Model Catalog: 680 2413 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: >10 serial numbers affected); Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2783 (Lot serial: 36000773)
  • Product Description
    VITROS 5600 Integrated System;VITROS 3600 Immunodiagnostics System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS