Events

Rappel de Device Recall cobas KRAS Mutation Test

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 Roche Molecular Systems, 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
    62500
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2159-2012
  • Date de mise en oeuvre de l'événement
    2012-02-24
  • Date de publication de l'événement
    2012-08-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110910
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Cause
    During the real-time stability testing for the cobas kras mutation test on the commercial lot po6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. the kit is labeled for 9 months shelf life stability. the d.
  • Action
    Roche issued a Safety Board Notice (Prooduct Support Notice 2012-01) and Product Bulletin 2012/03 dated February 24, 2012 to all affected customers. The notice idenfied the affected product, description of situation and actions to be taken. Customers were instructed to discontinue use of lot P06778 by March 4, 2012 and to quarantine and discard any remaining kits from lot P06778. The notice stated that a new lot will be made available as a replacement.

Device

Device Recall cobas KRAS Mutation Test
  • Modèle / numéro de série
    05852170190; Lot P06778
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey.
  • Description du dispositif
    Cobas KRAS Mutation Test for In Vitro Diagnostic Use || Product Usage: Usage: || The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA