Events

Alerte De Sécurité sur Magnetic Silica (MgSiL) Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Not applicable Affected Series Numbers: Z017DA1MS

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.; BIOMERIEUX AS.

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
    2122
  • Date
    2017-01-11
  • 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
    • Please share this information with all appropriate people in your laboratory. Keep a copy of this in your files. Pass the information to anyone who may be using this product, including those who may have downloaded this product. • Please complete the confirmation form, Attachment A, to let us know when this letter is received. • Please pick up the remaining units of this lot, in your inventory, fill in the form 018113 - Notification for collection of customer kits and return it to the Integrated Customer Service, so that bioMérieux can arrange to collect them. • Additional quality control tests have been applied since the first FSCA and allow us to monitor the performance and stability of MagSIL. The last monitoring as it was performed on 11/02/2016 for bioMérieux applications following the instructions for use. Then, a deviation in the performance of the kit was observed over time, which could lead to potential batch non-compliance and impact bioMérieux applications (after November 2016). • Discuss any concerns you may have about results prior to November 2016 with the laboratory's Medical Director to determine the appropriate action to take. #### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Cause
    History: a previous fsca (3037) was opened in july 2016, with performance problems for 25 lots placed on the market, of which only one (z017da1ms) was imported by biomérieux brasil; impacting downstream applications with platforms that do not belong to biomérieux, when: 1- the sample extraction volume is greater than 400 microliters. 2- when donwstream amplification focuses on the double strand of dna. the studies did not show significant performance impacts when using nuclisens extraction reagents, with ivd donwstream ivd amplifications validated by biomérieux (nasba and argene line). following the above fsca, additional controls were applied to batches made of magnetic silica: all silicas produced and released complied with manufacturer's quality control release tests. in addition, the performance of batches manufactured since august 2016 is being monitored in real-time stability, at two levels: a- for all released batches, in the worst case situation: bk test with 1ml of the specimen. this test mimics donwstream amplifications, which do not belong to biomérieux. b- for all unexpired lots, which are on the market (including lots already in fsca), with representative tests of biomérieux applications (rna and dna for the nasba and argene lines). a performance drift after a few months of validity was detected in some batches of magnetic silica, released after the first fsca (3037), for donwstream amplifications, not biomérieux. the donwstream biomérieux amplifications remain compliant. problem and impacts: during the monthly performance monitoring tests, the problem discussed was identified. all previous tests were in accordance with biomérieux applications.
  • Action
    Field Action Code FSCA 3285 triggered under the responsibility of bioMérieux Brasil Indústria e Comércio de productos Laboratoriais Ltda. Company will collect for further destruction.

Device

Magnetic Silica (MgSiL) Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Num...

Manufacturer

bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; BIOMERIEUX AS