Events

Rappel de Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) 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 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
    56247
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2653-2010
  • Date de mise en oeuvre de l'événement
    2010-06-28
  • Date de publication de l'événement
    2010-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93055
  • 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
    Immunoglobulin A (Ig-A) Reagent - Product Code DEW
  • Cause
    The recall was initiated after beckman coulter inc. confirmed reports of high recovery of immunoglobulin a (iga) in proficiency surveys or patient samples using synchron ig-a reagent lots m812164 or m902345. using these reagent lots, some samples deficient in iga have yielded results in the normal range. other samples with normal levels of iga have yielded falsely high results.
  • Action
    A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent. Customers were instructed to: (1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options. (2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. Customers were also instructed to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

Device

Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagent
  • Modèle / numéro de série
    Lot Numbers: M812164, M902345
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide & Canada
  • Description du dispositif
    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
  • 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