Events

Alerte De Sécurité sur Placental growth factor - Delfia Xpress PIGF kit, record 10298910109, hazard class II, lots 637790

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par PerkinElmer do Brasil Ltda.; Wallac Ou.

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
  • ID de l'événement
    1645
  • Date
    2015-07-22
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    According to the instructions for use the results should only be reported if the values ​​are within the range defined as acceptable. That is, incorrect results should not be reported to patients. The associated risk is due to delays in the screening of patients for pre-eclampsia and Down's syndrome in the first trimester.
  • Cause
    Problem related to the stability of lot 637341 of pigf calibrators of the delphia pigf kits (6007-0010, 6007-000 and 6007-002c). the problem is limited to a batch of the pigf calibrators, which is included in the described pigf kit lots. due to the stability problem, there is a tendency to decrease the signal level measured in the calibrators to 20%.
  • Action
    The company that holds the registration guides the immediate discontinuation in the use of the DELFIA Xpress PIGF kit lots highlighted in this field action. The kits should be destroyed. It is requested the analysis of the PIGF control values ​​for the enumerated lots, complete verification. In case QC controls are within acceptable range, the results of samples should be considered valid. If there are deviations, it is recommended to repeat the samples with another kit lot. The kits will be replaced by the manufacturer.

Device

Placental growth factor - Delfia Xpress PIGF kit, record 10298910109, hazard class II, lots 637790

Manufacturer

PerkinElmer do Brasil Ltda.; Wallac Ou