Events

Alerte De Sécurité sur ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUSES (HCV AG / ANTI-HCV) ANVISA registration number: 80020690319 Hazard class: IV Affected model: 480 tests / 96 tests Numbers of series affected: 6J0533, 6K0535, 6M0536 and 6K0534

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 Bio-Rad Laboratórios Brasil Ltda; Bio-Rad.

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
    2296
  • Date
    2017-05-19
  • 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
    As a result of this notification, we ask users to: • Continue to use affected kits and batches as long as the validation criteria are met (refer to the product use instruction (section 7.5) for detailed instructions): 1) For negative control R3 : OF 0.500 • Stop using batches affected if validation criteria fail.
  • Cause
    Decrease of all optical density (od) values ​​for samples and controls tested. this may result in board invalidation. the phenomenon that causes an overall decrease of all od values ​​appears a few months after the batch release. positive control of recombinant antigen - r5 (synthetic base peptide) is more affected by the decrease in od values ​​and results in invalidation of the run when its od becomes lower than 0.5. however, since the final results (reasons) are not impacted, there is no risk of incorrect result. reagent r6 (conjugate 1 - biotinylated monoclonal antibodies against hcv capsid antigen) was identified as the main cause of this decrease in od values.
  • Action
    Field Action Code Bio-Rad_AC-001/2017 triggered under the responsibility of Bio-Rad Laboratorios Brasil Ltda. Company will send a statement.

Device

ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUSES (HCV AG / ANTI-HCV) ANVISA registration number: 8002...

Manufacturer

Bio-Rad Laboratórios Brasil Ltda; Bio-Rad