Events

Recall of Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 701/702 modules. 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-2016-RN-01549-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01549-1
  • 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 diagnostics’ internal investigations found homocysteine reagent lots 173114 and 173121 can lead to under-recovery of results in quality controls (qc) and patient samples. the root cause of the issue has been identified to be the instability of the enzyme, homocysteine s-methyltransferase (hmtase) in reagent r2. lower recovery of affected reagent lots could lead to false low homocysteine results in the worst case scenario. this could further affect the interpretation of the potential risk of atherosclerosis and lead to a delay in diagnosis of atherosclerosis. however, since homocysteine is used for the estimation of long-term cardiovascular risk (late cardiac events), an adverse event due to this issue is extremely unlikely.
  • Action
    Roche is advising customers to immediately discard affected product. Roche will provide unaffected replacement stock. The under recovery issue should be discussed with the medical director to determine whether a look-back is required for previously affected patient results. This action has been closed-out on 26/05/2017.

Device

Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 7...
  • Model / Serial
    Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 701/702 modules. An in vitro diagnostic medical device (IVD).Homocysteine Enzymatic Assay (100 tests) Material Number: 05385415190Lot Number: 173114Homocysteine Enzymatic Assay (200 tests)Material Number: 06542921190Lot Number: 173121 ARTG Number: 174908
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited