Events

Rappel de Microscan Neg MIC 38, B1017412

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
    70893
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1533-2015
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • Date de publication de l'événement
    2015-04-27
  • 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=135438
  • 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
    Technical support bulletin issued in february 2013 did not mention performance limitation for proteus mirabilis and imp when using the clsim100-s20 revised interpretive criteria.
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: juntalan@beckman.com or your local Siemens technical support representative.

Device

Microscan Neg MIC 38, B1017412
  • Modèle / numéro de série
    Catalog number: B1017-412; Siemens Material Number (SMN):  10371535.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
  • Description du dispositif
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels || Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 || Breakpoints || Panel: Neg MIC 38, Catalog B1017-412 || Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed || for use in determining antimicrobial agent susceptibility and/or identification to the || species level of aerobic and facultatively anaerobic gram-negative bacilli.
  • 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