Events

Rappel de PhD System EIA/IFAversion 2.1A 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
    53690
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1495-2011
  • Date de publication de l'événement
    2011-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86329
  • 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, pipeting and diluting for clinical use - Product Code JQW
  • Cause
    Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the phd system with software version 2.1a.
  • Action
    BIO-RAD sent an URGENT: MEDICAL DEVICE CORRECTION letter dated September 29, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their customer records to identify all PhD System customers that are using version 2.1A of the EIA/IFA Software and Methods CD-ROM. Customers who are not running competitive immunoassays on the PhD System may continue using the 2.1A software. Customers who run competitive immunoassays must revert to software version 2.0B. Customers were instructed to translate if necessary and add local contact information to the customer letter and distribute to all PhD System customers that are using 2.1A of the EIA/IFA Software and Methods CD-ROM. A Customer Medical Device Correction Response Form must be collected from each customer to ensure that they have received this important communication. Once forms have been collected from all applicable customers, they should be faxed to Bio-Rad CSD Regulatory Affairs Department along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 510-741-3954.

Device

PhD System EIA/IFAversion 2.1A software
  • Modèle / numéro de série
    Model 426-0246, software version 2.1A
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, CA, CO, CT, DC, FL, IL, MA, MD, MN, MO, MS, MT, NC, NY, OH, PA, SD, TN, TX, UT, and VT and the countries of Australia, New Zealand, Singapore, China, France, Sweden, and Canada
  • Description du dispositif
    PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. || EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions.
  • 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
  • Source
    USFDA