Events

Alerte De Sécurité sur Calibrator Immunodiagnosis Vitros for 25-OH Vitamin D Total, Record no. 80145901419, lots: See Annex Distribution List.

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1351
  • Date
    2014-01-30
  • 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
    Research indicates that previous batches of the VITROS® 25-OH total vitamin D calibrator may have been equally affected by this problem, and therefore recommend that previously reported results be generated using VITROS® 25-OH vitamin D total calibrators , Lots 0091 to 0235. The laboratory may wish to review the quality control results used to verify deviations in calibration. Results lower than the target mean may indicate potentially biased test results. Discuss any concerns with the Laboratory Medical Director or the doctor who requested the examination. The results from this or any other diagnostic test should be used and interpreted only in the context of the whole clinical picture. The company informs that this event fits into the situation whose use of, or exposure to, the affected product may cause adverse health effects that are clinically reversible or temporary, or in which the likelihood of serious adverse health consequences is remote, as defined in legislation relevant.
  • Cause
    The company that owns the registry informs that a manufacturer's investigation, ortho clinical diagnostics, inc. (ocd), has identified that certain immunological products vitros® 25-oh vitamin d total calibrators, lot 0091 to 0235, used with the vitros reagent packs ® immunodiagnostic products 25-oh vitamin d total, may cause negative deviation in results. as a result, you should immediately discontinue use of all batches vitros® 25-oh vitamin d total calibrator and reagent (lots 0200, 0210, 0220, 0230 and 0235).
  • Action
    The company directs that: i- Immediately discontinue the use of VITROS® 25-OH Calibrator and Reagent Vitamin D Total (Lots 0200, 0210, 0220, 0230 and 0235); ii - Review the reported results from Lots 0091 to 0235 VITROS® 25-OH Vitamin D Total. Your lab can review QC results to verify calibration. Results below the target mean may potentially indicate deviation in the results; iii - Discuss any concerns with the Medical Director of the Laboratory or with the doctor who requested the examination; iv - Complete the receipt of this notification by February 15, 2014. See Letter to the Client, attached to this alert.

Device

Calibrator Immunodiagnosis Vitros for 25-OH Vitamin D Total, Record no. 80145901419, lots: See An...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda