Events

Rappel de Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory 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 Abbott Laboratories, 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
    63946
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0987-2013
  • Date de mise en oeuvre de l'événement
    2012-12-18
  • Date de publication de l'événement
    2013-03-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115090
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Cause
    Abbott has identified that assay files for the architect hbsag qualitative and hbsag qualitative confirmatory assays (lns 4p53 and 4p54) on the architect i1000sr system were mistakenly made available on abbottdiagnostics.Com in october 2012. additionally, some i1000sr customers received notification through abbottlink in november 2012 that assay files for lns 4p53 and 4p54 were available. the ar.
  • Action
    The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.

Device

Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay
  • Modèle / numéro de série
    All shipped out to this date
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
  • Description du dispositif
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 || The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Adresse du fabricant
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • 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