Events

Rappel de Device Recall PhD System EIA/IFA Software

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 Bio-Rad Laboratories, 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
    57778
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1726-2011
  • Date de mise en oeuvre de l'événement
    2011-01-20
  • Date de publication de l'événement
    2011-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97382
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Cause
    Firm's correction involves advising customers who have implemented a laboratory information system (lis) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. when a patient result fails a validation rule, the qualitative result will indicate "invalid".
  • Action
    The firm, Bio-Rad, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter. If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.

Device

Device Recall PhD System EIA/IFA Software
  • Modèle / numéro de série
    All versions.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.
  • Description du dispositif
    PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; || The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. || Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA