Events

Alerte De Sécurité sur 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

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Roche.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-05-05
  • Date de publication de l'événement
    2015-05-05
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150505b.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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...
  • Modèle / numéro de série
  • Description du dispositif
    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