Events

Alerte De Sécurité sur Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: Z017KB1MS / Z017LE1MS / Z017MA1MS and Z017NA1MS

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 bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A..

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
    2183
  • Date
    2016-12-09
  • 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
    Required actions: We request the following actions at the moment: - Please distribute this information to all appropriate personnel in your laboratory, keep a copy in your files and send this information to all parties who may use this product, including others who you may have downloaded our product. - Systematically use an internal extraction control that mimics the extracted target (with the same nature / structure) and / or external controls as recommended in the product manual and in the Laboratory Good Practices to detect any extraction problems. - In case of problem detected, reduce the sample inlet volume to 200μl. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Officer to determine the appropriate course of action. Please contact bioMérieux customer service if you notice the problem. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the customer safety warning with evidence from science and all actions completed.
  • Cause
    The problem was detected during additional control done on batches made of nuclisens easy mag magnetic silica (tests outside the manufacturer's quality control routine procedures). this additional test is a bk virus run application (amplification method) used to mimic the worst-case condition of a vol. above 1ml of specimen and a small-sized (5kbp) double-stranded genome. in addition the performance of the batches that were released was monitored in real-time stability at 02 levels: 1- in the worst case situation, in a bk test and 1ml of specimen. 2- with representative tests of biomérieux applications (rna & dna, argene line and nuclisens line). monitoring of performance, it was observed that after a few months of validity, there is a drift in the performance results with the bk test and 1ml of plasma (bk virus, worst case of application); for some batches nuclisens easymag magnetic silica. the observed performances for biomérieux applications, including the bkvirus r-gene (ref. 69-013b), remain in place over time when such applications are used in accordance with their instructions for use.
  • Action
    Field Action Code FSCA3203 triggered under the responsibility of bioMérieux Brasil Indústria e Comércio de productos Laboratoriais Ltda. Company will send guidance letter to clients.

Device

Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration N...

Manufacturer

bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A.