Events

Recall of Device Recall enGen Laboratory Automation System

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    74354
  • Event Risk Class
    Class 3
  • Event Number
    Z-2143-2016
  • Event Initiated Date
    2016-05-16
  • Event Date Posted
    2016-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147261
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    If the user selects the comment or interpretation option (in the engen .Gsb file), and the numerical results fall between negative and reactive, the im incorrectly displays the interpretive text as borderline and sends the incorrect text to the lis. the ifu states the interpretation term for these numerical result values is retest?.¿ the difference in terminology exists for us markets only.
  • Action
    Ortho Clinical Diagnostics sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter dated May 16, 2016, to all affected customers in the US with enGen Systems via FedEx or US Priority Mail (for Post Office Box addresses) or by e-mail to subscribers of ORTHO PLUS e-Communications to advise them of the issue and the required actions . Required Actions: 1. Use the numerical test results to assess actions to be taken for these assays, per the IFU. 2. Post this notification by your enGen System or with your user documentation. 3. Complete and return the Confirmation of Receipt form by 25 May 2016. with the Instructions for Use (IFU) directions). If you have any questions regarding this notification, please call the Ortho Technical Solutions Center at any time at 1-800-421-3311.

Device

Device Recall enGen Laboratory Automation System
  • Model / Serial
    Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283,  JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855,  JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167,  JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527,  JIM340024, JIM341021, JIM340658
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA