Events

Alerte De Sécurité sur VACUTAINER - TUBES FOR COMBUSTIBLE BLOOD COLLECTION - Reg. 10033430136. BD VACUTAINER GLASS TUBE WITH BLOOD PARAGLIDER REAGENT - Reg. 10033430313. BD VACUTAINER PLASTIC TUBE WITH BLOOD PARAGLIDER REAGENT - Reg.10033430261. TUBO VACUTAINER BD - Reg.10033430014

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 BECTON DICKINSON INDS CIRURGICAS 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
    784
  • Date
    2004-09-17
  • 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
    The company reports that although there is no case registered in Brazil and even if the differences found do not interfere in the diagnosis of the patient, since the clinical picture, the anamnesis, the physical condition and other complementary tests subsidize the diagnosis, to advise clients to use non-reagent tubes when clinical trials for determination of T3, T4 and Cortisol are performed on the following equipment: Total T3 - The use of BD Vacutaine® tubes without plastic gel separator (dry glass can be used as long as users have established their own reference values ​​using glass tubes) //////////////////////////// T 4 Total and Cortisol - It is recommended to use BD Vacutaine® tubes without plastic or glass separator gel
  • Cause
    Routine tests performed in the united states have identified that when these tubes are used in certain equipment the test results may be high compared to the unreacted tubes which are the tubes traditionally used for these types of determinations.
  • Action
    Both BD and equipment manufacturers are keen to understand the source of the differences in results to see if additional corrective or preventive action is needed. Verify that you have received a letter from the company BD with the following content //////////////// To: Customers using BD Vacutainer® SSTTM and SST ITMI (glass and plastic gel tubes) tubes for determinations of total T3, total T4 and cortisol in the DPC immunoassay system IMMULITE®, IMMULITE® 1000, IMMULlTE® 2000 and IMMULlTE® 2500.//////////////// Dear Customer, We have seen, by means of this, inform them that through routine tests it was identified that the values ​​of total T3, total T4 and cortisol, when obtained through the use of BD Vacutainer® SSTTM and SST IITM tubes (glass and plastic gel tubes) were elevated compared to tubes without gel separator when determinations were performed on the DPC IMMULITE®, IMMULITE® 1000, IMMULITE® 2000 and IMMULITE® 2500 equipment. We know that the results of these hormones should be interpreted with regard to the clinical picture, anamnesis, physical examination and the other subsidiary exams of the patient and. However, we report that the finding problem, although transitory, was only present in tubes manufactured in the United States and Europe. However, preventively, we recommend that the T4 total and cortísol total IT tests, when performed in these equipment, be collected in tubes without gel separator, according to the catalogs suggested in the annex. We would like to point out that all the measures have already been taken to understand the origin of the difference in results. We thank you in advance for your attention and we are at your disposal for any further clarification through our Scientific Advisory 51859960.

Device

VACUTAINER - TUBES FOR COMBUSTIBLE BLOOD COLLECTION - Reg. 10033430136. BD VACUTAINER GLASS TUBE ...

Manufacturer

BECTON DICKINSON INDS CIRURGICAS LTDA
  • Source
    ANVSANVISA