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
    61686
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-07
  • 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
    Ocd has identified an anomaly with vitros system software version 3.0 & below on the vitros 3600 immunodiagnostic system vitros 4600 chemistry system and vitros 5600 integrated system. internal testing confirmed that under very specific conditions incorrect patient demographics were associated with a sample identification (id) number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2783 (Lot serial: 36000130); 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