Events

Retiro De Equipo (Recall) de Biomerieux Vitek2 AST-YS07 Test Kits

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por BioMerieux Inc.

¿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
    18488
  • Fecha de inicio del evento
    2015-05-21
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • 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
    Manufacturer to issue advice regarding use

Device

Biomerieux Vitek2 AST-YS07 Test Kits
  • Modelo / Serial
    Model: Catalogue numbers: 414967, Affected: Lot numbers: 287314910, 287317310, 287323520, 287336220, 287340140
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc