Events

Rappel de Device Recall Access Ostase Calibrators

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
    61214
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1238-2012
  • Date de mise en oeuvre de l'événement
    2011-11-10
  • Date de publication de l'événement
    2012-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107579
  • 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
    Electrophoretic separation, alkaline phosphatase isoenzymes - Product Code CIN
  • Cause
    The recall was initiated because beckman confirmed that the access ostase calibrator and qc lots do not meet expiration date claims. the access ostase reagent kit lots identified were quality control tested and released using access ostase calibrator and qc lots that contain the implicated raw material.
  • Action
    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 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 use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.

Device

Device Recall Access Ostase Calibrators
  • Modèle / numéro de série
    Lot Numbers: Expiration dates: 013489 11/30/2010  111530 09/30/2011 013490 01/31/2011  113463 10/31/2011 015210 02/28/2011  114259 10/31/2011 018854 03/31/2011  114260 11/30/2011 020419 05/31/2011  115484 12/31/2011 022834 06/30/2011  116658 01/31/2012 109632 07/31/2011
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
  • Description du dispositif
    Access Ostase Calibrators, Part Number: 37305, || Subsequent Product Code: JIS. || The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA