Events

Rappel de Device Recall Triage Micro ClostrIdium difficile (C.difficile) Panel

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 Biosite Inc.

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
    46307
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1352-2008
  • Date de mise en oeuvre de l'événement
    2007-12-04
  • Date de publication de l'événement
    2008-03-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67162
  • 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
    Micro ClostrIdium difficile (C.difficile) Panel, - Product Code MCB
  • Cause
    False lower results: toxin a results in the triage micro c. difficile panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.
  • Action
    Consignees located in the United States received an Urgent Medical Device Recall Letter notification by United Parcel Service on 12/4/2007 and 12/14/2007. Consignees outside of the United States were notified by Federal Express on 12/4/2007 and 12/14/2007. The Customer Recall Letter with attached fax-back Verification form informed customers of the recall and instructed customers to dicontinue use, discard appropriately all affected kits and complete and FAX the enclosed Verification form. Contact information was also provided form the recalling firm. (USA-(800) 640-0640 )

Device

Device Recall Triage Micro ClostrIdium difficile (C.difficile) Panel
  • Modèle / numéro de série
    Lot Numbers: 180263, 187303, 181472, 183607, 181471, 188135, 185593, 186624, 187398, 190790, and 189158
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide- USA, Argentina, Australia, Belgium, Canada, Switzerland, Colombia, The Czech Republic, Germany, France, Greece, Guatemala, Hong Kong, Croatia, India, Italy, Mexico, Portugal, Sweden, Turkey & The United Kingdom
  • Description du dispositif
    Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121
  • Manufacturer
    Biosite Inc

Manufacturer

Biosite Inc
  • Adresse du fabricant
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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