Events

Alerte De Sécurité sur Roche Calibrator Ammonia / Ethanol / CO2, Anvisa registration no. 10287410069, Lots no. 17907001 and Roche Ammonia / Ethanol / CO2 controls, Anvisa registry nº 10287410079, lots of normal control 178993 01 and abnormal control 179021 01 and 179021 02.

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 Roche Diagnostics Operations Inc.; Roche Diagnostica Brasil Ltda.

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
    917
  • Date
    2008-05-09
  • 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
    Report any Adverse Event or Technical Complaint related to the use of the products object of this Alert to Anvisa through the Notivisa System: http://www.anvisa.gov.br/hotsite/notivisa/index.htm The distribution list by state is available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_917_lista.pdf
  • Cause
    In previous alert (a9546) the ecri institute reported that the vials containing the reagents listed at http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/alerta_917_produtos.Pdf may have been leaked during transportation, potentially resulting in false bicarbonate values ​​when affected batches of calibrators are used in combination with abnormal and normal controls. the affected bottles had signs that they were broken during the manufacturing process. roche announced that a limited replacement provision for the affected bottles is available. the number of these lots available for substitution were also listed in the document available at the link above. the manufacturer initiated a recall action through the health product pickup urgent letter dated february 13, 2008.
  • Action
    Make sure you have received the Product Pickup Urgent Letter dated February 13, 2008, and fax the form submitted by Roche. Identify and isolate any affected product from your stock. Roche will replace all affected products in your inventory and advises that your healthcare facility should contact your Distributor or contact Customer Service CARD 0800 772 0295 to have the product reset scheduled.

Device

Roche Calibrator Ammonia / Ethanol / CO2, Anvisa registration no. 10287410069, Lots no. 17907001 ...

Manufacturer

Roche Diagnostics Operations Inc.; Roche Diagnostica Brasil Ltda