Events

Recall of Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-00783-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00783-1
  • 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
    Previously, roche had received complaints about high recovery of the vancomycin assay in the context of external survey samples. to correct this, a lc-ms/ms reference method for the quantification of vancomycin was developed and released in 2014. as a result of this, updated instrument factors were required to correct possible high recovery and to align the various roche analysers. for the cobas integra system a slight adaptation of the reagent components is required instead of an updated instrument factor. since the cobas integra reagent is not yet adapted, results generated with this reagent are still higher by up to 20% in comparison to the cobas c modules or the modular analytics p-module. the method comparison in the ifu may lead to the assumption that both methods are comparable which may affect the interpretation of vancomycin test results.
  • Action
    Incorrect method comparison will be deleted from the IFUs. Corrected IFU will be provided to all users. In the interim, Roche is advising users to disregard the incorrect method comparison in the Instructions for Use (IFU).

Device

Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)
  • Model / Serial
    Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)Online TDM Vancomycin Material Number: 04491050190Instrument affected: cobas c 501/502 moduleHitachi VancomycinMaterial Number: 04642481190 Instrument affected: MODULAR ANALYTICS P-MODULEARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited