Events

Rappel de Inverness Medical BioStar Strep A OIA MAX

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 Binax, Inc. dba IMPD.

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
    51871
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1506-2009
  • Date de mise en oeuvre de l'événement
    2009-04-06
  • Date de publication de l'événement
    2009-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81490
  • 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
    strep test in vitro diagnostic - Product Code GTZ
  • Cause
    Potential for false positive strep a results.
  • Action
    Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.

Device

Inverness Medical BioStar Strep A OIA MAX
  • Modèle / numéro de série
    All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09;  196278, 196279, 196280, and 196281, expire 06/30/09.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, || Product Code: 90003, in vitro diagnostic.
  • Manufacturer
    Binax, Inc. dba IMPD

Manufacturer

Binax, Inc. dba IMPD
  • Adresse du fabricant
    Binax, Inc. dba IMPD, 10 Southgate Rd, Scarborough ME 04074
  • 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