Events

Recall of Elecsys Anti-HAV assay run on the Elecsys 2010 and cobas e 411 analysers, cobas e 601/602 modules and Modular Analytics E-Module. 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 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-2017-RN-00186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00186-1
  • 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
    Roche have determined that the performance of the elecsys anti-hav assay is affected by certain types of plasma specimens. when li-heparin and na-heparin plasma specimens were compared to serum samples during internal investigations, the specified required recovery could not be achieved. values were found to be on average up to 35 % below those obtained in serum. this under-recovery may occur across the entire measuring range. a false negative result may occur only where heparin plasma samples are within close proximity to the medical decision point of the assay at 20 iu/l. in all other cases, interpretation of the results would be unchanged. based on these findings, li- and na-heparin plasma specimens will no longer be claimed to be acceptable specimen types in the ifu. in addition, for k3-edta & citrate plasma specimens, the specified criterion in the ifu that the recovery compared to serum specimens has to be within 90-110 % has been broadened to 80-120 %.
  • Action
    The Elecsys Anti-HAV IFU will be updated to remove Li-heparin or Na-heparin plasma as acceptable specimen types and to include the following limitation: For plasma treated with lithium heparin or sodium heparin, the values found were up to 35 % lower than those obtained in serum. In addition, for the acceptable specimen types K3-EDTA and sodium citrate plasma, the criterion for mean recovery will be updated to 80-120 % of serum value. Users are advised to take note of the updated limitations and not use Li-heparin or Na-heparin plasma specimens with the assay. Laboratories should also consider retesting in accordance with relevant clinical information, if they suspect discrepant results with Li- and Na-heparin plasma specimens or have specific questions.

Device

Elecsys Anti-HAV assay run on the Elecsys 2010 and cobas e 411 analysers, cobas e 601/602 modules...
  • Model / Serial
    Elecsys Anti-HAV assay run on the Elecsys 2010 and cobas e 411 analysers, cobas e 601/602 modules and Modular Analytics E-Module. An in vitro diagnostic medical device (IVD).Material Number: 04854977190All lotsARTG number: 268492
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited