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
    121013
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-07
  • 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 (ocd) internal testing has confirmed instances where vitros 51 fs 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen regardless of the pretreatment requirements for each selected assay potentially leading to biased patient results. urine samples for use with vitros ca mg and phos slides require acidification (pretreatment). the engen system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. in addition the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. depending upon the assay urine samples need to be acidified alkalized extracted or not treated prior to being processed on vitros systems.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Model / Serial
    Model Catalog: ENGEN (Lot serial: J953234); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J1HX7S4J); Model Catalog: ENGEN (Lot serial: J953244); Model Catalog: ENGEN (Lot serial: JCT20Q3J)
  • Product Description
    ENGEN LABORATORY AUTOMATION SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS