Alerte De Sécurité sur Trade name: Creatinine PAP FS. Technical Name: Creatinine. ANVISA registration number: 10350840205. Risk class: II. Affected model: R1: 4 x 100 mL + R2: 2 x 100 mL. Serial numbers affected: 23842

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 BIOSYS LTDA; DiaSys Diagnostic Systems GmbH.

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
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Customers / users who have purchased batches related to this notification are advised by telephone and email to always follow the guidelines of Good Laboratory Practice and perform (pass / rotate) a control by replacing the R2 reagent bottle. If the recovery of the control shows a deviation of more than +/- 15% from the previous results, recalibration is required. In addition, an internal statement will be posted on the carton kits that are still in stock, reminding you of the need to use one control at each R2 bottle exchange for re-calibration of the assay, if necessary. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 07/14/2017 - Date of notification notice to Anvisa: 08/17/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    Biosys ltda., the registered trademark holder, has received a statement from the international manufacturer of the product, diasys diagnostic systems gmbh, stating that individual bottles of reagent r2 may show a change in coloration, which may lead to deviations in results, due to the increase in reagent blank. the deviation in the result can only occur if an unmodified reagent bottle r2 is replaced by another bottle of modified reagent r2, or vice versa, without further recalibration. thus, the risk of a deviation from the patient's outcome is only associated with replacement of r2 bottles without recalibration, since reagent performance is not affected, even with the more intense staining of some r2 bottles. biosys informs that it has not received a customer complaint related to the products in question.
  • Action
    Field Action Code 4529 triggered under the responsibility of the company BIOSYS LTDA. Company will update the instructions for use.