Events

Recall of VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)

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-00254-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00254-1
  • 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 received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using vitros chemistry products phbr slides. an investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
  • Action
    End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.

Device

VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quanti...
  • Model / Serial
    VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)GEN 38. Coating 0060GEN 39. Coating 0062GEN 40. Coating 0063GEN 41. Coating 0064Expiry date range: 1 April 2013 through 1 February 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics