Events

Retiro De Equipo (Recall) de ETEST products. An in vitro diagnostic medical device (IVD).Ceftazidime TZ256 (F) WW, Ceftriaxone TXL32 SPB WW, Ceftriaxone TXL32 (F) WW, Ciprofloxacin CI 32 (F) WW, Vancomycin VA 256 (F) WW, Benzyl Penicillin PG256 (F) WW, Fosfomycin FM1024 (B) WW, Gentamicin GM256 (F) WW, Tobramycin TM256 (F) WW

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-2017-RN-00185-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-03
  • 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-2017-RN-00185-1
  • 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
    Biomérieux have found that the current shelf-life claims of multiple etest products are not supported by internal testing. there is potential to obtain a mic result that is higher than expected after 24 months for fm1024 (b) ww, after 48 months for gm256 (f) ww and tm256 (f) ww, and after 12 months for the remainder of the affected products. this type of error would be detectable during qc testing as an out of range mic result would be obtained. patient results may also be elevated resulting in a false resistant result. accordingly, the shelf-life claims have been revised to 24, 48 and 12 months, as appropriate. when used within the revised shelf-life, the products will continue to perform per the labelled performance specifications.For etest ceftriaxone products there is also a potential performance issue on strain categorisation for streptococcus pneumoniae strains when using the 2016 clsi or 2016 eucast guidelines. there is potential to obtain a false susceptible result.
  • Acción
    bioMérieux is advising customers to identify impacted lots of the ETEST products and take note of the new expiry dates. Customers are to discontinue using and discard the expired lots. Credit will be provided for expired product. Lots that have remaining shelf life can continue to be used. For ETEST Ceftriaxone TXL32 SPB WW lots that may have a strain categorisation issue, laboratories can continue to use the ETEST if they apply the recommendations provided in the customer letter. ETEST Ceftriaxone TXL32 (F) WW has been discontinued and customers can transition to ETEST Ceftriaxone TXL32 SPB WW. It is recommended that customers consider retrospective analysis of patient results.

Device

ETEST products. An in vitro diagnostic medical device (IVD).Ceftazidime TZ256 (F) WW, Ceftriaxone...
  • Modelo / Serial
    ETEST products. An in vitro diagnostic medical device (IVD).Ceftazidime TZ256 (F) WW, Ref. 506718Ceftriaxone TXL32 SPB WW, Ref. 412303Ceftriaxone TXL32 (F) WW, Ref. 507018 Ciprofloxacin CI 32 (F) WW, Ref. 508610, 508618 Vancomycin VA 256 (F) WW, Ref. 525510, 525518 Benzyl Penicillin PG256 (F) WW, Ref. 502518Fosfomycin FM1024 (B) WW, Ref. 529100, 529108Gentamicin GM256 (F) WW, Ref. 512518 Tobramycin TM256 (F) WW, Ref. 522718Multiple Lot NumbersARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd