Events

Rappel de Device Recall Active Cortisol EIA

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 Beckman Coulter Inc..

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
    55227
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2761-2011
  • Date de mise en oeuvre de l'événement
    2009-07-20
  • Date de publication de l'événement
    2011-07-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90374
  • 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, cortisol - Product Code CGR
  • Cause
    The recall was initiated because beckman coulter has confirmed that the listed lot numbers of active control elisa reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. beckman coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica.
  • Action
    Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below. Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification. Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.

Device

Device Recall Active Cortisol EIA
  • Modèle / numéro de série
    Lot Numbers Epiration Dates 04195 8/15/2006 04195A 10/18/2006 04195B 1/26/2006 04195D 8/15/2006 04195E 10/18/2006 04195F 10/18/2006 09266A 01/31/2006 09266 10/17/2007 04126A 10/11/2007 04126 7/28/2007 03066A 09/05/2007 03066 09/05/2007 01036 07/02/2007 716217 06/06/2008 716218 07/29/2008 800408 05/07/2009 800409 05/07/2009 800410 05/07/2009 890829 09/03/2009 990168 09/03/2009
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Description du dispositif
    Active Cortisol EIA, 96 Wells, DSL-10-2000 || The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA