Events

Rappel de Device Recall SimpliRED Ddimer Assay

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par BBI SOLUTIONS OEM LTD.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74786
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0314-2017
  • Date de mise en oeuvre de l'événement
    2016-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148459
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Fibrin split products - Product Code GHH
  • Cause
    A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. qualitative results may be affected. false negative results are possible which may incorrectly influence the clinical diagnostic decision.
  • Action
    BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44(0)1382 564093.

Device

Device Recall SimpliRED Ddimer Assay
  • Modèle / numéro de série
    Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution to CT and IN
  • Description du dispositif
    SimpliRED D-Dimer, Product Code DSRK4 || The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
  • Manufacturer
    BBI SOLUTIONS OEM LTD

Manufacturer

BBI SOLUTIONS OEM LTD
  • Adresse du fabricant
    BBI SOLUTIONS OEM LTD, 8 Tom McDonald Avenue, Dundee United Kingdom
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA