Events

Recall of VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ortho-Clinical Diagnostics Australia Pty Ltd.

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
    RC-2016-RN-01547-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01547-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ortho is providing additional information for a product correction notification that was issued in december 2015 (rc-2016-rn-00017-1) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors and observed that wash errors were occurring at a higher than expected rate for vitros phyt slides. it was determined that vitros systems could sometimes identify false wash errors. if a u90-382 or 6lu code is generated, the vitros system suppresses the result and “no result” is reported (and review of previously reported results is not necessary).Ortho has identified an improvement to the wash algorithm that will help reduce false wash errors while not compromising the detection of true wash errors. this improvement involves a change to the magenta wash tolerance (mwt) limit and will be implemented on calibration diskette/assay data diskettte (add) drv 5910 and above.
  • Action
    Ortho is advising users to install Calibration Diskette or ADD DRV 5910 or above on their VITROS system. An automatic download will be available for e-Connected systems as of December 2, 2016. The Calibration Diskette and/or ADD will also be sent to the customer's facility when available. After loading DRV 5910 (or above) for the first time, VITROS PHYT Slides will un-calibrate and will require recalibration. In the interim, the product can continue to be used.

Device

VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in ...
  • Model / Serial
    VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD). VITROS Chemistry Products PHYT SlidesProduct Code: 8298671 Lot Numbers: all current (in date) lotsCalibration Diskette (Product Code: 8716607) & Assay Data Diskette (ADD) (Product Code: 6801876) versions (DRV) 5909 and belowARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd