Events

Rappel de MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

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
    48692
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1396-2009
  • Date de publication de l'événement
    2009-05-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-05-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71908
  • 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
    Myoglobin, antigen, antiserum, control - Product Code DDR
  • Cause
    Beckman coulter initiated the field action as a result of recent internal testing following the clsi ep-5a - evaluation of precision performance of clinical chemistry devices protocol, it was determined that the total imprecision for the access myoglobin reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. based on internal tes.
  • Action
    An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.

Device

MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
  • Modèle / numéro de série
    All Lot Numbers.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada.
  • Description du dispositif
    Access Myoglobin Reagents Kits, Part Number: 973243. || The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin 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, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA