Events

Rappel de Device Recall Image Upgrade Kit, Catalog 92019C

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.

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
    66293
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0032-2014
  • Date de mise en oeuvre de l'événement
    2013-08-20
  • Date de publication de l'événement
    2013-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122026
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Cause
    The fse image upgrade kit (part 92019c) is recalled due to issue related to the export of data from the evolis analyzer to laboratory information systems (lis) when using the monolisa anti-hbs eia quantitative determination in evolis apf version 6.0.
  • Action
    BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.

Device

Device Recall Image Upgrade Kit, Catalog 92019C
  • Modèle / numéro de série
    Lot 122822
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
  • Description du dispositif
    FSE Image Upgrade Kit, Catalog # 92019C || This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Adresse du fabricant
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA