Events

Retiro De Equipo (Recall) de Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). 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 Bio-Rad Laboratories 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-2018-RN-00495-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-17
  • 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-2018-RN-00495-1
  • 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
    Bio-rad have received multiple customer complaints indicating that some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert stated ranges, namely high cvs.The performance of level 1, lot 68511 is not impacted.To date, there have been no reports of injury or illness as a result of this issue.
  • Acción
    Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2). Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.

Device

Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains...
  • Modelo / Serial
    Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)Liquichek Urine Chemistry Control Level 2Catalogue Number: 398Lot Number: 68512Expiry Date: 30 Sept 2019Liquichek Urine Chemistry Control MiniPak (contains Level 2)Catalogue Number: 395XLot Number: 68510Expiry Date: 30 Sept 2019ARTG Number: 206309(Bio-Rad Laboratories - Clinical chemistry biological screening IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd