Events

Rappel de Device Recall SYNCHRON System(s) Rheumatoid Factor (RF) 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
    56397
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1743-2011
  • Date de mise en oeuvre de l'événement
    2010-06-21
  • Date de publication de l'événement
    2011-03-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93465
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • Cause
    The recall was initiated because beckman coulter testing indicated that rheumatoid factor (rf) reagent lot m907325 will not remain stable to the labeled expiration date.
  • Action
    The firm Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated June 25, 2010 to the consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: *Discontinue use and discard appropriately Rheumatoid Factor (RF) reagent lot M907325 *Contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss reagent replacement options. *Complete and return the FAX BACK RESPONSE FORM via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., Brea, California 92821, Mail Code E2.SE.08 Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If consignees/customers forwarded the affected products listed above to another laboratory, then they need to also provide a copy of the Product Corrective Action letter to the laboratory. If they have any questions regarding this Product Corrective Action letter, consignees were told to call Beckman Coulter Customer Support Center (Hotline) at (800) 854-633 in the United States and Canada.

Device

Device Recall SYNCHRON System(s) Rheumatoid Factor (RF) Reagent
  • Modèle / numéro de série
    Lot #M907325
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Description du dispositif
    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 || RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
  • 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