Events

Recall of Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia 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
    RC-2013-RN-01257-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01257-1
  • 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-clinical diagnostics, inc. (ocd) has determined that the default dilution factors on the calibration diskette (cal disk) and assay data disks (add), drv 5740 and below, are incorrect. it has also been determined that the 2nd dilution factors contained in the engen laboratory automation system configuration (.Gsb) file (version 3.2.2 & below) are incorrect.
  • Action
    Ortho-Clincial Diagnostics is providing their customers with Local Cal Disk or ADD version 5741 which contains the correct dilution factors. Customers are also advised to review their LIS data to determine the impact of the revised default dilution factors. For those customers using the enGen system, an Ortho-Clinical Diagnostics representative will assist in the development of revised dilution factors. This action has been closed-out on 12/02/2016.

Device

Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro dia...
  • Model / Serial
    Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD)VITROS Chemistry Instruments: -VITROS 4600-VITROS 5600-VITROS 250-VITROS 350-VITROS 5,1 FS-enGen systemVITROS Chemistry Products:ALT slides -1655281 CK slides -8479396, -8478034LDH slides -8384489 hsCRP reagent -6801739 THC reagent -6801994 TIBC kit -8867541 METD reagent -6801996 CRBM slides -8892382
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics