Events

Recall of VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II

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
    80204
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-29
  • 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
    There is a software issue that may affect results from diluted samples run on the vitros eci immunodiagnostic system tested with the vitros immunodiagnostics products total beta-hcg ii reagent pack. ocd has received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct 'no result' which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample which was within the measuring range of 2.39-15000 miu/ml.

Device

VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Model / Serial
    Model Catalog: 863 3893 (Lot serial: Lots 0484 and above); Model Catalog: 1922814 (Lot serial: Lots 0484 and above)
  • Product Description
    VITROS ECi/ECiQ Immunodiagnostic Systems Software V 3.8 & below/VITROS Immunodiagnostic Products Total beta-hCG II Reagent Packs Lots 0484 & Above
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS