Events

Recall of VITROS 5600 INTEGRATED SYSTEM - SOFTWARE

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
    90870
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-28
  • 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 51 fs system version 2.6.1 software and below and vitros 5600 integrated system software version 2.0 and below. for the ease of workflow vitros analyzers allow multiple lots of the same reagent to be on board the system at the same time. the system automatically switches to the next lot when the "in use" lot is depleted or when the operator manually changes the lot that is in use. in this issue following a successful calibration of the new gens of vitros vanc [vancomycin] reagent (gen 21 and up) or vitros valp [valproic acid] reagent ( gen 16 and up) the system can unexpectedly switch and use the previous (old) lot on board the system to process post-calibration quality control samples. if the operator doesn't notice the lot switch condition code (pv2-097) posted on their screen the new calibration may not be verified by the proper quality control (qc) verification. based on that biased results could potentially occur from a calibration that is suboptimal.

Device

VITROS 5600 INTEGRATED SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: 680 2864 (Lot serial: > 10 contact manufacturer.); Model Catalog: 6801886 (Lot serial: > 10 contact manufacturer.)
  • Product Description
    VITROS 5600 Integrated System Software Version 2.0 & Below
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS