Events

Rappel de VITROS 4600 Chemistry System

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
    70917
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1742-2015
  • Date de mise en oeuvre de l'événement
    2015-04-06
  • Date de publication de l'événement
    2015-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135517
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
  • Action
    On April 6, 2015, Ortho Clinical Diagnostics distributed correction notification letters and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1-800-421-3311 anytime..***CAPA***Since the Assay Data Disk (ADD) provides data tables that determine which assays can be tested from the same sample container, an updated ADD is being created to address the anomaly on the VITROS 4600 and 5600. The anomaly will be addressed with an updated ADD is uploaded and the revised ADD mitigates the issue totally. Anticipated date of availability TBD.

Device

VITROS 4600 Chemistry System
  • Modèle / numéro de série
    Product Code: 6802445 Unique Device Identifier No.: 10758750012343
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
  • Description du dispositif
    VITROS 4600 Chemistry System, Software Version 3.2 & Below. || Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Société-mère du fabricant (2017)
    The Carlyle Group LP
  • Source
    USFDA