Events

Recall of ORTHO BioVue System Cassettes (blood typing and compatibility tests). 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-00721-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00721-1
  • 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 has identified isolated occurrences of improperly positioned cassette labels resulting in the barcode, lot number, expiration date and sequence number placed on the incorrect side of the cassette. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection.This issue potentially affects abd confirmation cassettes, rh/k cassettes, rh-hr cassettes, abo-dd grouping cassettes, abo-rh grouping cassettes and anti-human globulin neutral solution (poly/neutral cassettes).
  • Action
    Ortho-Clinical Diagnostics (OCD) is requesting customers to discard any potentially affected lots. OCD is recommending discussion of previously reported patient results with the Laboratory Medical Director to determine the appropriate course of action. OCD can provide detailed information regarding the impact to previously reported results for each type of cassette. Please contact OCD for further information.

Device

ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medi...
  • Model / Serial
    ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medical device (IVD).Multiple products affectedARTG Number: 31036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics