Events

Rappel de Device Recall VITROS Chemistry Products PHBR Slides

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
    60831
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1117-2012
  • Date de mise en oeuvre de l'événement
    2011-06-23
  • Date de publication de l'événement
    2012-02-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106599
  • 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
    Enzyme immunoassay, phenobarbital - Product Code DLZ
  • Cause
    Ortho clinical diagnostics (ocd) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of vitros¿ chemistry products phbr slides (phenobarbital) from coating 0053.
  • Action
    Ortho Clinical Diagnostics sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated June 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using and discard all remaining lots of the affected product. A Confirmation of Receipt Form was attached so customers may complete and return to the firm. The firm recommends that customers consult with their Laboratory Medical Director and requesting physician to resolve any concerns they may have regarding previously reported results. Contact Customer Technical Services at 1-800-421-3311 for questions regarding this notification.

Device

Device Recall VITROS Chemistry Products PHBR Slides
  • Modèle / numéro de série
    Lot numbers: 2532-0053-4961 (exp. 2/01/12), 2532-0053-4984 (exp. 2/01/12), 2532-0053-4996 (exp. 3/01/12), 2532-0053-4997 (exp. 3/01/12), 2532-0053-0144 (exp. 3/01/12), 2532-0053-0149 (exp. 3/01/12), 2532-0053-0217 (exp. 3/01/12), 2532-0053-0615 (exp. 4/01/12), 2532-0053-0616 (exp. 4/01/12), 2532-0053-1472 (exp. 5/01/12), 2532-0053-1488 (exp. 5/01/12), 2532-0053-1489 (exp. 5/01/12), 2532-0053-1490 (exp. 5/01/12) [Note the four middle numbers (0053) of the above Lot #s constitute the Coating #].
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
  • Description du dispositif
    VITROS¿ Chemistry Products PHBR Slides, REF 822 1384 || --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. || For in vitro diagnostic use only. VITROS¿ Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

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