Events

Alerta De Seguridad para crea plus, crep2, lact2, lactate, glu, trigl/tg, triggb, trig/gb, chol/chol2, hdl-c plus 3rd generation/hdlc3, ldl_c plus 2nd generation/ldl_c, ua2/ua plus

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Roche.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-05-05
  • Fecha de publicación del evento
    2015-05-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150505b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: roche crea plus, crep2, lact2, lactate, glu, trigl/tg, triggb, trig/gb, chol/chol2, hdl-c plus 3rd generation/hdlc3, ldl_c plus 2nd generation/ldl_c, ua2/ua plus medical device manufacturer, roche, has issued a medical device safety alert concerning all lot numbers of crea plus, crep2, lact2, lactate, glu, trigl/tg, triggb, trig/gb, chol/chol2, hdl-c plus 3rd generation/hdlc3, ldl_c plus 2nd generation/ldl_c, ua2/ua plus. the manufacturer has received complaints about falsely low crea plus results for patients with a toxic level of acetaminophen under treatment with n-acetylcysteine (nac). the manufacturer has received complaints about falsely low crea plus results for patients with a toxic level of acetaminophen under treatment with n-acetylcysteine (nac). the manufacturer’s investigations suggest that the peroxidase reaction is interfered with by certain drugs, causing falsely low recovery. the manufacturer advises user to be aware that: the recovery of trinder tests may be falsely low when the blood sample is taken while levels of nac, napqi, and metamizole are still present. venipuncture should be performed prior to the administration of metamizole. venipuncture immediately after or during the administration of metamizole may lead to falsely low results. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 may 2015.

Device

crea plus, crep2, lact2, lactate, glu, trigl/tg, triggb, trig/gb, chol/chol2, hdl-c plus 3rd gene...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [5 May 2015] Roche CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus
  • Manufacturer
    Roche

Manufacturer

Roche