Events

Rappel de Device Recall VITROS Signal Reagent

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
    35020
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0765-06
  • Date de mise en oeuvre de l'événement
    2006-03-28
  • Date de publication de l'événement
    2006-04-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45148
  • 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
    Radioimmunoassay, Total Triiodothyronine - Product Code CDP
  • Cause
    Firm received complaints of biased results when using vitros signal reagent, lots 8350 and 8530. vitros signal reagent is used with the vitros immunodiagnostic eci/eciq laboratory system, and when used may produce inaccurate test results in some cases.
  • Action
    Ortho-Clinical Diagnostics sent "Urgent Product Correction/Recall Notification" letters, dated 3/28/06, to the customers via overnight mail. Ortho-Clinical Diagnostics issued a nationwide press release on 3/31/06. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians. Ortho-Clinical Diagnostics has advised laboratories, using this reagent, to contact the patient's physician if there are any concerns regarding previous test results. Customers with questions may contact the company at 1-800-421-3311. Additionally, Ortho-Clinical Diagnostics notified all end users of the VITROS ECi/ECiQ Immunodiagnostic System in the US and globally.

Device

Device Recall VITROS Signal Reagent
  • Modèle / numéro de série
    Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Medical facilities nationwide and 1 foreign affiliate in Canada.
  • Description du dispositif
    VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA