Events

Rappel de Device Recall ENA6 Screen Enzyme Immunoassay Test Kit

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 Diamedix Corporation.

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
    61568
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1620-2012
  • Date de mise en oeuvre de l'événement
    2011-06-08
  • Date de publication de l'événement
    2012-05-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108435
  • 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
    Extractable antinuclear antibody, antigen and control - Product Code LLL
  • Cause
    On 06/08/2011 diamedix corporation initiated a recall of is-ena-6 screen test kit, catalog # 720-320 master lot s0000, exp. date may 31, 2012. the labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
  • Action
    Diamedix Corporation sent a Customer notification letter dated June 8, 2011, to all affected customers via Certified Mail. Customers were instructed to search their inventory and to return affected product to Diamedix. Diamedix apologizes for any inconvenience this has caused our valued customers. Please contact the Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any kits you might still have of the lot in question. Please rest assured that Diamedix values you as a customer and is in the process of taking the proper corrective and preventive actions.

Device

Device Recall ENA6 Screen Enzyme Immunoassay Test Kit
  • Modèle / numéro de série
    Catalog No. 720-230
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
  • Description du dispositif
    Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" || For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Adresse du fabricant
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source
    USFDA