Events

Retiro De Equipo (Recall) de EliA Sample Diluent

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus ALS 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-00348-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-10
  • 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-00348-1
  • 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
    There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the above-mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument, which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim, located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results, mainly a false positive, with regard to all elia assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message “3-145 right arm liquid detection below lower limit with target 2”.
  • Acción
    Users are notified to stop using the affected lots and record the lot numbers and quantity of any unused products prior to discarding them. Abacus ALS will organise replacements at no charge. Also, users are advised to discuss the contents of the letter with the Medical Director to ascertain if any further actions are required.

Device

EliA Sample Diluent
  • Modelo / Serial
    EliA Sample DiluentArt. No. 83-1023-01Lot Numbers: JM3Y, JS0B, JP87, JK5N, JU9CBottle Lots: BVXDR/JM3W, BVXDT/JS0A, BVXDS/JP83, BVXDP/JK5M, BVXDU/JU9BARTG Number: 229543
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd