Events

Recall of ORTHO VISION ANALYZER

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
    113889
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-15
  • 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 identified that under specific circumstances the saline supply on the ortho vision analyzer may be insufficient to process tests without operator knowledge. if an operator opens the liquid access door for any reason the system software automatically resets assuming the saline container was refilled to the maximum volume of 4700 ml regardless of whether the operator refills the saline container or not. if an operator opens the liquid access door and does not refill the saline container to 4700 ml the system loses track of the actual onboard saline volume. therefore the system can no longer accurately determine low saline volume levels and alert the operator.

Device

ORTHO VISION ANALYZER
  • Model / Serial
    Model Catalog: 6904577 (Lot serial: > 10 contact manufacturer)
  • Product Description
    ORTHO VISION Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS