Events

Rappel de Device Recall IMMAGE Immunochemistry Systems

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
    57750
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2045-2011
  • Date de mise en oeuvre de l'événement
    2010-08-24
  • Date de publication de l'événement
    2011-04-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97319
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Reagent, general purpose - Product Code LDT
  • Cause
    The recall was initiated because beckman coulter has confirmed an immage¿ systems wash solution lot 71744 was manufactured by a beckman european facility and not intended to be used in the u.S. however, this lot was inadvertently shipped to the u.S. and delivered to five customers.
  • Action
    The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage¿ Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967; package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products. If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.

Device

Device Recall IMMAGE Immunochemistry Systems
  • Modèle / numéro de série
    Lot Numbers: 71744
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Nationwide distribution: USA including states of : AL, CA, MI and IN.
  • Description du dispositif
    IMMAGE¿ Immunochemistry Systems Wash Solution Part Number: 447060 || The IMMAGE¿ Immunochemistry Systems Wash Solution is intended for use with IMMAGE¿ Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE¿ Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
  • 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