Events

Rappel de Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

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 ORTHO-CLINICAL DIAGNOSTICS.

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
    68890
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2183-2014
  • Date de mise en oeuvre de l'événement
    2014-07-16
  • Date de publication de l'événement
    2014-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128956
  • 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
    System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
  • Cause
    Customers may receive positively biased results when using vitros¿ immunodiagnostic products ca 19-9 total reagent packs, lot 1320 and vitros¿ ca 19-9 calibrators, lot 1320 on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. there is an unexpected observed change in ca 19-9 calibrators, lot 1320 calibrator values.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification July 2014 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to Immediately discontinue using and discard Lots 1320 of VITROS CA 19-9 Calibrators and Reagent Packs. Review previously reported VITROS 25-OH Vitamin D Total results using Lot 1320. Review quality control results used to verify calibration events. Results lower than the target mean may indicate potentially biased assay results. Discuss any concerns regarding previously reported results with the Laboratory Medical Director or with the requesting physician. Complete and return the attached Confirmation of Receipt form. OCD will: credit their account for all VITROS¿ CA 19-9 Calibrators and Reagent Packs that were discarded or ship repalcment product uspon request. Customers were instructed to forward the information in this notification if they have distributed this product outside of their facility. Customers with questions were instructed to contact their Customer Technical Service representative or contact the Customer Technical Service representative at 1-800-421-3311.

Device

Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators
  • Modèle / numéro de série
    Lot 1320, Product code: 6800035 and 6800040
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
  • Description du dispositif
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 || VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Adresse du fabricant
    ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA