Events

Alerte De Sécurité sur Products Affected :. Product VITROS® Immunodiagnostic Reagent Kit for β-hCG II Total --Register no. 80145901052 -> Code 6802220 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 1470 -> Class II. VITROS® Immunodiagnostic Calibrators for β-hCG II Total --Register nº80145901051 -> Code 6802221 -> Lots 1410, 1420, 1430, 1440, 1450, 1460, 147 -> Class II

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 INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA.; ORTHO CLINICAL DIAGNOSTICS, INC.

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
    1836
  • Date
    2016-03-21
  • 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
    Ortho's research identified that the results generated using plasma samples showed positive deviations compared to the use of serum samples for the same patient. Our data indicate that the samples expected to be below the measurement range (<2.39 mIU / mL (IU / L)) may potentially be reported at 7.72 mIU / mL (IU / L). Ortho recommends that you review previously reported Beta-hCG results of <9.00 mIU / mL (IU / L) for plasma samples processed using the affected batches. Talk to your Lab Medical Director about any questions you may have about previously reported hCG results to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture.
  • Cause
    Ortho clinical diagnostics (ortho) has confirmed that in performing tests using the batches listed above, vitros® systems generated results within the measurement range for samples known to have no measurable hcg. customers reported that their vitros® system generated results of up to approximately 7.40 miu / ml (iu / l) for patient samples that should be below the test measurement range (<2.39 miu / ml (iu / l )).
  • Action
    The company will promote the collection of the product and subsequent destruction. Action Code: 16000022. According to the company, the customer shall: I. Immediately discontinue use and dispose of all remaining inventory of batches listed above VITROS® Reagent Calibrators and Kits for Total β-hCG II. The company will replace your remaining inventory or make a credit to your account, as indicated on the Receipt Confirmation form; II. Review previously reported results using affected batches of VITROS® Reagent Kits for Total β-hCG II. III. Contact your Laboratory Medical Director regarding any questions regarding previously reported results to determine the appropriate course of action. IV. Insert this notification into your VITROS® System or together with your documentation. LETTER TO THE CUSTOMER IN ANNEX.

Device

Products Affected :. Product VITROS® Immunodiagnostic Reagent Kit for β-hCG II Total --Register n...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA.; ORTHO CLINICAL DIA...