Events

Retiro De Equipo (Recall) de 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).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01549-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01549-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / 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