Events

Alerte De Sécurité sur GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Class: I Affected Model: 2021-0010 Affected serial numbers: 20210154, 20210207, 20210171, 20210163, 20210161, 20210208.

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
    2193
  • Date
    2016-09-02
  • 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
    Defective insulation will be replaced during the next scheduled periodic maintenance visit or service visit. The visit can also be scheduled if requested by the client.
  • Cause
    We are aware that the insulation of the heated incubator door is defective in the instrument serial numbers listed above due to a change in the insulation production method. the film may come loose from the outer surface of the insulation, causing a mechanical motion error or a temperature control error. due to the defect, the instrument's operations will stop and it will require repair by perkinelmer field service engineers. instrument performance is only affected when error occurs in mechanical movement or temperature control. the operation of the heated incubator is involved during the incubation steps of the gsp neonatal galt (3303-0010 and 3303-001u) and gsp neonatal biotinidase (3307-0010, 3307-001u) assays which require a high temperature (+ 37 ° c ). the functionality of the heated incubator door is also checked during the instrument start procedure.
  • Action
    Field Action Code 2016.06.005461 triggered under the responsibility of the company PerkinElmer do Brasil Ltda. Company will make correction in the field.

Device

GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Cl...

Manufacturer

PerkinElmer do Brasil Ltda.; Wallac Ou