Events

Retiro De Equipo (Recall) de Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction

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 manufacturer #1479.

¿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
    18632
  • Fecha de inicio del evento
    2015-06-10
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Due to information received from the field, the potential interference of sulfasalazine and sulfapyridine in the alanine amino-transferase (alt) tests was investigated. the interference through sulfasalazine and sulfapyridine was checked for all tests using nad(h) or nadp(h). this study was done with the following strongly elevated plasma concentrations which correspond to the clsi-guideline ep-7-a2:, - 754 micromol/l sulfasalazine (300 mg/l), - 1.2 mmol/l sulfapyridine (299 mg/l), the interference depends on the pharmacokinetic and the clinical status of the patient (e.G. liver and kidney function, bowel resection etc.), which makes it impossible to provide exact information about serum drug concentration and half time.
  • Acción
    Instructions for use to be updated

Device

Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) re...
  • Modelo / Serial
    Model: Multiple catalogue numbers, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479