Events

Rappel de Device Recall MicroScan Neg Breakpoint Combo 34

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
    70874
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1522-2015
  • Date de mise en oeuvre de l'événement
    2014-05-14
  • Date de publication de l'événement
    2015-04-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135379
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Cause
    Siemens healthcare diagnostics has received complaints regarding panel degradation with a portion of the microscan neg breakpoint combo 34 (nbp34) panel lot 2014-05-28.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031

Device

Device Recall MicroScan Neg Breakpoint Combo 34
  • Modèle / numéro de série
    Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
  • Description du dispositif
    MicroScan -Neg Breakpoint Combo Panel Type 34; || Catalog number B1017-404; Panel || MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to || No.1 the species level of colonies, grown 34 on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.
  • Adresse du fabricant
    Beckman Coulter, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA