Events

Recall of VITROS Immunodiagnostic Products Signal Reagent. 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 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-2017-RN-01090-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01090-1
  • 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 (ocd) updated the reagent pack (i.E. bottle) for vitros signal reagent, beginning with lot 4492. some customers have reported that their vitros 3600 or 5600 system cannot detect the presence of the vitros signal reagent pack when using lot 4492 or above.An investigation by ocd determined that sensors on the vitros system may not detect the base of the updated vitros signal reagent packs due to a larger indentation at the base of the reagent pack. as a result, some vitros 3600 or 5600 systems may not be able to continually detect vitros signal reagent packs in the load positions or during testing at the in-use position.If the sensor cannot detect the base of the pack, that pack cannot be used to process samples.
  • Action
    If the VITROS 3600 or 5600 System cannot detect the presence of VITROS Signal Reagent Packs, users are to contact the Ortho Care Technical Solutions Centre for immediate assistance. An Ortho trained service representative will schedule the installation of MOD C3. Complete the Confirmation of Receipt form supplied with customer letter and if the affected lots were distributed to a different location, please forward the notification on.

Device

VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)Product Code: 1072693Lot Numbers: 4492 and aboveExpiry: 13 Aug 2017 and later (as until this issue is resolved, future lots may be affected)ARTG: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd