Events

Recall of VITROS Chemistry Products C-reactive protein (CRP) Slides

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-2016-RN-01427-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01427-1
  • 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 (ortho) received reports of positively biased crp results using vitros crp slides when diluting samples. investigation undertaken by ortho identified that samples diluted (3x recommended dilution or higher) using vitros chemistry products specialty diluent, vitros chemistry products fs diluent pack 3 or a low crp concentration sample had positively biased results if the endogenous level of crp in the diluent is not subtracted from the final result. the magnitude of bias increases as the dilution factor increases.
  • Action
    Users are advised to follow the instructions in the customer letter to perform dilutions when processing samples above the measuring range for CRP. VITROS CRP Slides Instructions for Use (IFUs) will be revised to include the additional instructions to follow when diluting samples with results above the measuring range. Discuss any concerns regarding previously reported CRP results with the Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. This action has been closed-out on 26/05/2017.

Device

VITROS Chemistry Products C-reactive protein (CRP) Slides
  • Model / Serial
    VITROS Chemistry Products C-reactive protein (CRP) SlidesProduct Codes: 1926740, 8097990Unique Identification Numbers: 10758750000296, 10758750004355Affected Generations (GENs): 3, 11, 12, 30 through 36This issue may affect expired, current (in date) and future product GENsARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd