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
    95389
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-30
  • 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 (ocd) has identified an anomaly with vitros system software version 3.1. internal testing confirmed that when using calibrator barcode labels supplied with vitros chemistry products calibrator kit 2 calibration may not occur under specific circumstances. consignees are being advised not to use the calibrator barcode labels for vitros calibrator kit 2 until this anomaly is resolved in a future version of software.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2413 (Lot serial: 56000576)
  • Product Description
    VITROS 5600 INTEGRATED SYSTEM (DEVICE LICENCE #78571)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS