Events

Recall of VITROS Performance Verifier I for unconjugated bilirubin (Bu)

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-2015-RN-00465-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00465-1
  • 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
    Investigations have been performed by ortho clinical diagnostics to investigate and address an increase in customer complaints generated for low outside the range of means pv level i results on multiple vitros bu reagent lots and multiple vitros pv lots. review of the customer complaints indicate that some customers are observing results that are outside the range of means (rom), within 0.1 mg/dl of the low end.The differences observed in bu range of means capabilities are not clinically significant and the accuracy of the patient sample results is not impacted by this situation, however there is potential for results to be delayed.
  • Action
    New Assay Sheets containing the revised Range of Means for Bu have been made available on the VITRIOS website. This action has been closed-out on 02/05/2017.

Device

VITROS Performance Verifier I for unconjugated bilirubin (Bu)
  • Model / Serial
    VITROS Performance Verifier I for unconjugated bilirubin (Bu)Product Code: 8067324 AUST L 25922Lot numbers: A3823, C4084, Q2961, T3161, V3297, X3569 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics