Events

Alerte De Sécurité sur VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Registration Number: 80145900933 Hazard Class: II Affected Model: Kit consisting of: 100 coated wells; 8.2 ml of conjugated reagent; 8.2 ml of biotinylated antibody reagent. Serial numbers affected: SKU: 6802156 | Lot: 1620

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; Ortho-Clinical Diagnostics.

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
    2295
  • Date
    2017-05-21
  • 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
    If a successful calibration is currently possible, implement the revisions in your system: o For VITROS® ECi / ECiQ Systems: At your next scheduled calibration, scan the Yellow Magnetic Batch Card from Lot 1620. Discard / Destroy Lot Card Magnetic original (green), supplied with the product. o For VITROS 3600, 5600 Systems: Install ADD DRV 5932 and later using the "Full Load" (All Assay Data) option. After loading the ADD for the first time, the VITROS Reagent Kits for NT-proBNP will lose the calibration and must be recalibrated. After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory. NOTE: For e-Connected systems, download will be available around Saturday, May 13, 2017. • If Lot 1620 can not be calibrated, upon availability, use the new Magnetic Batch Card or ADD DRV 5932 to calibrate. • If you have this problem and no longer wish to use this product, Ortho will credit your account for the discarded product. • Place this notification next to each system that processes the VITROS Reagent Kits for NT-proBNP.
  • Cause
    Vitros reagent kits for nt-probnp, lot 1620, showed the potential for a higher frequency of calibration failures, with an unexpected increase in the calibrator level 1 signal, potentially causing a failure of the calibration parameters. tests indicate that calibration failure is related to a component of the vitros reagent kit for nt-probnp and is not associated with the vitros calibrators for nt-probnp. the investigation confirmed that the increase in signal does not affect the sampling results (ie, quality control or patient samples) within the 28-day calibration cycle.
  • Action
    Field Action Code TC2017-098 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Reg...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics