Events

Rappel de Device Recall Inhibin A ELISA 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 Beckman Coulter 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
    57866
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1925-2011
  • Date de mise en oeuvre de l'événement
    2010-12-21
  • Date de publication de l'événement
    2011-04-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97616
  • 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
    Enzyme immunoassay, inhibin-a - Product Code NDR
  • Cause
    The recall was initiated because the lots of inhibin a identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action letter dated December 21, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and discard all remaining inventory. In addition customers were requested to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form within 10 days so Beckman could be assured that customers received this important notification. For product replacement: 1. In the United States, please contact Customer Service at 1-800-526-3821, option 1. 2. In Canada, please contact Customer Service at 1-800-463-7828. 3. Outside of the United States and Canada, contact your local Beckman Coulter representative. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. For those customers outside the United States and Canada, instructions were given to contact their local Beckman Coulter representative.

Device

Device Recall Inhibin A ELISA Kit
  • Modèle / numéro de série
    Lot #: 090779 (EXP: 02/04/2011), 091046 (EXP: 02/16/2011), 091053(EXP: 11/09/2011)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including NY, IN, PA, NM, OH, TX, AZ, NC, TN, MI and CT and the countries Denmark, Germany, Spain, Turkey, United Arab Emirates, United Kingdom.
  • Description du dispositif
    Inhibin A ELISA kit, Part Number: DSL-10-28100-4 || The Inhibin A ELISA kit is intended for the quantitative measurement of Dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA