Events

Rappel de Device Recall VITROS Chemistry Products CDM PROM

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
    68840
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2214-2014
  • Date de mise en oeuvre de l'événement
    2014-07-15
  • Date de publication de l'événement
    2014-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128837
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Cause
    Inability to calibrate or use vitros nh3 dt slides, gen 59 with vitros chemistry products dt calibrator kit, lot 44 when cdm prom 0168 or 0169 is installed on vitros dt60/dt60 ii chemistry systems.
  • Action
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44. Customers were instructed to forward this notice if the product was further distributed outside of their facility. OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59. Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products CDM PROM
  • Modèle / numéro de série
    Lots 0168 and 0169
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Description du dispositif
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 1000 Lee Road, Rochester NY 14606
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA