Events

Alerte De Sécurité sur A: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 7.0: (1) MODEL 3332 VITROS 250, (2) MODEL 3391 VITROS 250 AT; B: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 3.07: (3) MODEL 3360 VITROS 950, (4) MODEL 3361 VITROS 950 AT

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 ORTHO-CLINICAL DIAGNOSTICS INC A JOHNSON & JOHNSON CO..

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
    67
  • Date
    2001-05-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The results of non-conjugated bilirubin can result less than 0.0 mg / dl or the results of the conjugated bilirubin can not sign the potential interference codes when a spectral interference is existed in a sample of the patient. the problem may occur in some laboratory information systems depending on the data transfer mode.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE LETTER OF OCTOBER 6, 2000 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. . IDENTIFY THESE SYSTEMS THAT MAY BE WITH AFFECTED VERSIONS IN YOUR INVENTORY. ORTHO-CLINICAL DIAGNOSTICS AFFIRMS THAT VERSION 7.0 OR MORE FOR THE SITEMAS VITROS 250 OR 250 AT CORRECTED THE PROBLEM. SOFTWARE TO CORRECT THE PROBLEM WITH 950 AND 950 VOTES AT STILL NOT AVAILABLE. IF REPORTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN ARE REQUIRED, ORTHO-CLINICAL DIAGNOSTICS RECOMMENDS THE FOLLOWING: (1) REVIEW ALL REPORTS OF RESULTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN; (2) IF THE RESULTS OF NON-CONJUGATED BILIRUBIN ARE LOWER THAN THE ANALYZER INTERVAL, DO NOT REPORT THE CORRESPONDING CONJUGATED BILIRUBIN RESULT. (3) DO NOT USE THE PRINTED MONITOR RESULTS TO REPORT RESULTS OF UNLESS CONNECTED BILIRUBIN ANALYSIS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.

Device

A: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 7.0: (1) MODEL 3332 VITROS 250, (2...

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC A JOHNSON & JOHNSON CO.