Events

Alerte De Sécurité sur Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​/// Risk Class: II - products of medium risk to the individual and / or low risk to public health, subject to registration /// Lots: 69781101 /; 69781401; 69780301 (SCHEDULE OF DISTRIBUTION IN ANNEX)

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 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical.

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
    1549
  • Date
    2015-04-10
  • 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
    Actions to be taken by the customer / user, according to the company: • Customers must stop using the affected product (affected batches), eliminating it locally and switching to subsequent batches of HCYS that are not affected: Batch Affected: 69780301 / 69781101/69781401 - Expiry date30 / 04/2015 - Using Subsequent Batches: 607116101/60716801/60717101 - Validity 1/31/2016
  • Cause
    The company reported that "customers complained of a 20% decrease in control levels when using non-roche controls (eg, thermofisher liqimmune) with the reagent homocysteine ​​from lot 697811 on cobas c 501 equipment. lot 604303, controls were within range. comparison of patient samples with reagent lot 697811 versus lot 604303 showed a deviation of up to 54%. plasma samples were used in edta. this negative deviation could result, in the worst case, in low homocysteine ​​results. however, it is unlikely that inaccurately low homocysteine ​​results could have caused an immediate adverse event, since homocysteine ​​has been shown to be an indicator of long-term cardiovascular risk (late cardiac events) rather than short-term events. ".
  • Action
    Company communicated its customers by letter (LETTER IN ANNEX) Type of action: Notice to Customers and Distributors not to use affected lots (LETTER IN ANNEX) /// Code: SBN_RPD_2015_006

Device

Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​//...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical