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. Affected batch / serial numbers: SKU 6802156, lot 1570, 1580

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
    2263
  • Date
    2017-04-11
  • 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 you are currently able to perform a successful calibration, implement the revisions on your VITROS System at your next scheduled calibration: o For VITROS® ECi / ECiQ Systems: Scan the Magnetic Batch Card for Batch 1580 or 1590. Discard / Original Magnetic Batch Card (green), supplied with the product. o For VITROS 3600, 5600 Systems: Install ADD DRV 5923 and later. Install the ADD 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 is available as of March 13, 2017. • If it is not possible to calibrate Batches 1580 or 1590, upon availability, use the new Magnetic Batch Card or ADD DRV 5923 for calibration. • If you have this problem and you no longer wish to use this product, Ortho will credit your account for the discarded product, or you will reimburse it for another product you have indicated. Resend the Receipt Confirmation form to indicate the amount that requires credit. • Place this notification next to each system that processes the VITROS Reagent Kits for NT-proBNP.
  • Cause
    Ortho clinical diagnostics (ortho) informs about the potential inability to obtain a successful calibration using the batches listed below the vitros reagent kits for nt-probnp. it was confirmed that affected batches of vitros reagent kits for nt-probnp showed the potential for a higher frequency of calibration failures, with an unexpected increase in the level 1 calibrator signal, potentially causing a failure of the calibration parameters. our preliminary tests indicate that the 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. ortho is working to determine the root cause. until the cause is identified, the company will monitor all current and future batches to monitor performance and issue additional notifications and corrective / preventive actions, as appropriate.
  • Action
    Field Action Code TC2017-048 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make field alert.

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