Events

Recall of VITROS 3600 IMMUNODIAGNOSTIC 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
    63028
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-20
  • 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 and below. ocd determined that the software may not properly identify an expired calibration. calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. ocd's investigation confirmed that if the anomaly occurs a calibration may expire but the system may not alert the operator and not flag results with a ce sample result code (i.E. calibration expired). the system may unexpectedly generate results even though it is configured to not report results when a calibration has expired.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2783 (Lot serial: 36000130); Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2413 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 680 2445 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (LICENCE #80702)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS