Events

Recall of ENGEN AUTOMATED SAMPLE HANDLING SYSTEM

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
    102936
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-25
  • 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 internal testing has determined that when a sample requires follow-up action such as dilution or retesting due to a mechanical issue it is possible for that sample to be routed to the sample storage drawer prior to completion of the necessary pending action. a delay in patient test result(s) reporting could occur. this affects engen laboratory automation systems configured with data innovations llc instrument manager v8.06.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Model / Serial
    Model Catalog: ENGEN (Lot serial: JIM341055); Model Catalog: ENGEN (Lot serial: JIM340814); Model Catalog: ENGEN (Lot serial: JIM340432); Model Catalog: ENGEN (Lot serial: JIM341130)
  • Product Description
    ENGEN LABORATORY AUTOMATION SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS