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
    96863
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-09
  • 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 inc. (ocd) initiated this recall due to the potential for used dilution wells to be reused. reuse of dilution wells can occur if: - an ocd field engineer performs a clean-up of the analyzer database or if an operator restores a database backup on the analyzer and - dilution trays have not been removed from the instrument prior to restarting the system. in this situation the analyzer software cannot identify usage history of the dilution wells on the instrument and reuse of wells may occur.

Device

ORTHO VISION ANALYZER
  • Model / Serial
    Model Catalog: 6904577 (Lot serial: 50002035); Model Catalog: 6904577 (Lot serial: 50002033); Model Catalog: 6904577 (Lot serial: 50002032); Model Catalog: 6904577 (Lot serial: 50002031); Model Catalog: 6904577 (Lot serial: 50002037)
  • Product Description
    ORTHO VISION Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS