Events

Recall of ORTHO PROVUE

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
    93022
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-11
  • 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 (ortho) has initiated this recall to customers with an ortho provue analyzer on which the reader camera brightness value (brillo) was detected to be outside of the specified range. the approved specification for the ortho provue? reader camera brightness is 101 to 128. exceeding the upper range limit of 128 could potentially affect the classification of very low strength (<1+) reactions and may grade the reactions negative instead of as indeterminate ("?"). however the risk is reduced by the fact that any processed cards are read at the same camera brightness (brillo) setting that was established at the time that the reference image was created after optics alignment and adjustment procedures were performed.

Device

ORTHO PROVUE
  • Model / Serial
    Model Catalog: MTS213784 (Lot serial: 057-171-1749)
  • Product Description
    ORTHO ProVue Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS