Events

Alerte De Sécurité sur Trade name: Nuclisens Lysis Buffer. Technical Name: Nuclisens Lysis Buffer. ANVISA Registration Number: 10158120527 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: 16092902

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
    2230
  • Date
    2017-03-17
  • 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
    Destroy the remaining stock of units in lot 160092902 of Nuclisens Lysis Buffer that are still in stock. ### 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. There was no product distributed in Brazil.
  • Cause
    It was identified, after receiving customer complaint, colored eluents for extractions of whole blood when using the nuclisens batch lysis buffer: 16092902. due to this fact an investigation was opened in the laboratory of research and development related to this product (pr 1082674). open investigation (pr1082674) has confirmed that the eluent becomes colored due to the presence of hemoglobin in the blood samples, including dry blood spot. in the case of dry blood spot, the investigation highlighted some cases of inhibition even though the eluents remain slightly colored. the root cause of the staining is linked with a non-compliance in terms of ph value of the lysis solution. it has been found that the ph of the solution in this batch is 6.9 when the ph specification for this solution is 7.1 +/- 0.1. research has confirmed that the presence of hemoglobin may cause inhibition of downstream applications (pcr / rtpcr / nasba etc ....), resulting in uninterpretable results in most cases. because the internal controls would also be inhibited, we would invalidate the test. in this case the risk is related to the delay in the emission of the diagnostic results. however, considering that the nuclisens lysis buffer is used in various protocols and downstream applications; and assuming a conservative positioning, we can say that the worst case scenario would be: internal control is not inhibited or not used, although this is part of the good laboratory practice procedures, the color eluent tests could have a potential result false negative investigations have confirmed that we have no other batch of the nuclisens lysis buffer on the market today presenting the same problem of non-compliance with ph.
  • Action
    Field Action Code FSCA 3337 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Company will not do any field action because no kit was put on the market.

Device

Trade name: Nuclisens Lysis Buffer. Technical Name: Nuclisens Lysis Buffer. ANVISA Registration N...

Manufacturer

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