Events

Rappel de Device Recall COULTER LH 500 Series System

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
    61255
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1243-2012
  • Date de mise en oeuvre de l'événement
    2011-12-01
  • Date de publication de l'événement
    2012-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107671
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    The recall was initiated because beckman coulter has confirmed that the auto stop and auto transmit features for quality control become disabled after scanning assay values from coulter 5c and retic-c cell controls assay sheets using the 2d barcode scanner.
  • Action
    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.

Device

Device Recall COULTER LH 500 Series System
  • Modèle / numéro de série
    Not available.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiopia France Germany Greece Guadeloupe Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Macao Malaysia Mayotte Mexico Monaco Morocco Myanmar Namibia Netherlands New Zealand Norway Oman Pakistan Panama Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Trinidad and Tobago Tunisia Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam Yemen Zimbabwe
  • Description du dispositif
    COULTER LH 500 Series System , || part number: LH500 System Help 2A4.103271; || LH 500 Series System 100V, PN 178832; || LH 500 Series System 120V, PN 178833; || LH 500 Series System 240V, PN 178834; || LH 500 Series System Remanufactured (115V), PN A91062; || LH 500 Series System Remanufactured (220V), PN A90994 || SW Version 2A4, 2A5. || Serial Number: all. || The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA