Events

Recall of Elecsys Beta-CrossLaps. 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-2013-RN-00388-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00388-1
  • 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 is revising the package insert claims for the sample stability (serum and heparinised plasma) and biotin interference of elecsys beta-crosslaps. the package insert will be updated to reflect the results of recent internal testing for sample stability testing and biotin interference as follows:- the sample stability claim for serum kept at 20-25 degrees celcius will be revised from 8 hours to 6 hours- the sample stability claim for heparinised plasma kept at 20-25 degrees celcius will be revised from 24 hours to 4 hours- the sample stability claim for heparinised plasma kept at 4-8 degrees celcius will be revised from 24 hours to 8 hours. - the biotin interference claim "the assay should be unaffected by biotin up to 368nmol/l or 90 ng/ml" will be revised to "the assay should be unaffected by biotin up to 123nmol/l or 30ng/ml".
  • Action
    Roche Diagnostics are providing updated information that reflects the results of recent internal testing. A package insert update will include these changes from August, 2013.

Device

Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited