Events

Rappel de Device Recall VITROS Chemistry Products Calibrator Kit 29

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
    74363
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2119-2016
  • Date de mise en oeuvre de l'événement
    2016-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147279
  • 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
    Ferrozine (colorimetric) iron binding capacity - Product Code JMO
  • Cause
    Ortho clinical diagnostics started receiving customer complaints for biased results when using vitros dtibc reagent gen 30 product. ortho's investigation confirmed that incorrect calibration mathematics were assigned to the calibrator kit 29 lots 2915 and 2995 supporting dtibc reagent gen 30 product.
  • Action
    Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 24, 2016, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to discontinue using the affected product until Assay Data Diskette (ADD) Data Realease Version (DRV) 5884 or above was installed on their VITROS System. Foreign affiliates were informed of the issue via e-mail on 5/24/2016 and instructed to notify their consignees of the issue and required actions. Customers with questions were advised to contact Ortho's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.

Device

Device Recall VITROS Chemistry Products Calibrator Kit 29
  • Modèle / numéro de série
    Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.
  • Description du dispositif
    VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics || For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
  • 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