Events

Retiro De Equipo (Recall) de VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits

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

¿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-2015-RN-00378-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-01
  • 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-2015-RN-00378-1
  • 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
    An issue related to out-of-range-low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258, the package insert qc strain, has been identified in association with the vitek 2 ast-ys06 and ast-ys07 test kits.Internal investigation at the manufacturing site has observed the oorl fct qc results for candida krusei atcc 6258. internal testing of fct with additional isolates shows a trend to call one to two doubling dilutions low. candida krusei are intrinsically resistant to fct and are therefore forced "resistant" in vitek 2 software (as of version 7.01); the vitek® 2 7.01 fct forcing rule does not apply to other candida species. user reports have been limited to the atcc 6258 qc strain; however, impact to patient results for candida krusei and other yeast cannot be ruled out.
  • Acción
    For the referenced test kits (VITEK 2 AST-YS06 or AST-YS07), laboratories are advised to not report Flucytosine (FCT) results for any organism until the new formulation (fct02n) is released. This issue will be resolved with the release of a new Flucytosine (fct02n) formulation. The estimated timeframe for introduction of cards with the new Flucytosine formulation is six months. This action has been closed out on 09/08/2016.

Device

VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits
  • Modelo / Serial
    VITEK2 AST-YS06 & VITEK2 AST-YS07 Test KitsCatalogue numbers: 412610 & 414967Lot numbers: 286303720, 287314910, 287314912, 287317310, 287318920, 287321940, 287323520, 287329620, 287330520, 287334810, 287336220, 287340140, 287344620, 287344622, 287346710, 287350120 & 287350910Pack size: 20 CardsARTG number: 196634
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd